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NerPharMa

Full company profile

uuid000aim2

Namestring
NerPharMa
Legal namestring
Nerpharma S.r.l
Websiteurl
nerpharma.com
Company typeenum
Private
Founded yearint
2010
Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
51–100
akta.pro rankint
HeadquartersNerviano, Italy
HQ citystring
Nerviano
HQ countrystring
Italy
HQ regionstring
Europe
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
contract pharmaceutical manufacturing, oncology drug development, active pharmaceutical ingredients, sterile injectable manufacturing, high potency manufacturing
Industry5 codes
PRIMARYHLAGABAB
Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Development & Manufacturing Organizations (CDMO)
SECONDARYHLAGABAA
Small-Molecule API & Intermediates CDMO
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Development & Manufacturing Organizations (CDMO)
SECONDARYHLAGABAK
Clinical Trial Material (CTM) Manufacturing & Supply CDMO
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Development & Manufacturing Organizations (CDMO)
SECONDARYHLAGAHAM
Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC)
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/API & Small-Molecule Development/Manufacturing Services
SECONDARYHLAGAHAL
GMP Scale-Up, Tech Transfer & Process Validation (PPQ)
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/API & Small-Molecule Development/Manufacturing Services
NAICS code2 codes
  • Pharmaceutical and Medicine Manufacturing32541
  • Pharmaceutical and Medicine Manufacturing3254
SIC code2 codes
  • Pharmaceutical Preparations2834
  • Services-Commercial Physical & Biological Research8731
Product category
Pharmaceutical Contract Manufacturing Services (CDMO)
Social media profiles1 record
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model1 record
1Contract Development and Manufacturing Services
TypeProfessional Services
Description

NerPharMa generates revenue through providing GMP-compliant contract manufacturing services for pharmaceutical active ingredients (API/drug substance) and finished pharmaceutical products (drug product). Services include development and scale-up, regulatory support, clinical supply, and analytical services. The company operates as a CDMO with both DS and DP divisions serving global pharmaceutical clients.

nerpharma.com
Marketing channels4 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components6 values
Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain, Marketing or Sales
Pricing details1 tier
1Contract-based manufacturing services for pharmaceutical companies
ModelOther
Notes

Quote-based / Not publicly disclosed - pricing varies by project complexity, batch size, and regulatory requirements

nerpharma.com
GTM typeB2B
B2B
Offering typeServices
Services
Core offering1 text field

NerPharMa is a Contract Development and Manufacturing Organization (CDMO) specializing in oncology, operating two divisions—NerPharMa DS (Drug Substance) for high-potency active pharmaceutical ingredient (API) manufacturing including Protein Kinase Inhibitors and cytotoxic/cytostatic compounds, and NerPharMa DP (Drug Product) for injectable products (solutions, suspensions, lyophilized) and oral solid products (tablets, capsules). The company provides integrated services including API development and scale-up, contract manufacturing, clinical supply, regulatory support, and analytical services for global pharmaceutical and biotechnology clients.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 3 values shown
  • More than 15 products successfully commercialized
+2 more records
Product overview1 text field

NerPharMa operates as a Contract Development and Manufacturing Organization (CDMO) specializing in oncology, with two core divisions: NerPharMa DS (Drug Substance) and NerPharMa DP (Drug Product). NerPharMa DS develops and manufactures active pharmaceutical ingredients exclusively for oncology (Protein Kinase Inhibitors, cytotoxic/cytostatic compounds) from laboratory to commercial scale. NerPharMa DP supports development and production of injectable products (solutions, suspensions, lyophilized products) and oral solid products (tablets, capsules). The company offers integrated services including development and scale-up, contract manufacturing, regulatory services, clinical supply, and analytical services. The company has over 15 products on the market, with unique innovative technologies including dual chamber bags and HyNap nanoparticle technology.

Product and service6 records
1NerPharMa DS (Drug Substance) Manufacturing
CategoryContract API Manufacturing
Description

Development and manufacturing of active pharmaceutical ingredients (APIs) exclusively for oncology applications including Protein Kinase Inhibitors, cytotoxic and cytostatic compounds, from laboratory scale to commercial production under cGMP with multi-regulatory approval (FDA, EMA, AIFA, ANVISA Brazil, China FDA, PMDA Japan, Russia).

2NerPharMa DP (Drug Product) Manufacturing
CategoryContract Drug Product Manufacturing
Description

Contract development and production of injectable products (solutions, suspensions, and lyophilized products) and oral solid products (tablets and capsules) for various therapeutic areas, handling Protein Kinase Inhibitors, cytotoxic and cytostatic products, with formulation, packaging, and distribution activities. Authorized by AIFA for medicinal product manufacture and packaging.

3Development and Scale-up Services
CategoryPharmaceutical Development Services
Description

Full support from API synthetic route development through formulation, process development, analytical methods, scale-up, technology transfer, regulatory filing support, and commercial manufacturing for pharmaceutical clients.

4Regulatory Services
CategoryRegulatory Affairs Services
Description

Guidance and consulting in IMPD, IND, DMF, CMC and dossier preparation and filing, with CMC section support for IND, NDA, and ANDA filings across the EU, US, and Japan for pharmaceutical clients.

5Clinical Supply Services
CategoryClinical Trial Supply Services
Description

Manufacturing, labeling, packaging, and distribution of investigational medicinal products from laboratory to production scale for Phase 1 through Phase 4 clinical studies, including patient kit assembly combining primary and associated drug products.

6Analytical Services
CategoryAnalytical Testing Services
Description

Comprehensive analytical testing including method development and validation, ICH stability studies, dissolution profiles, impurity characterization, and full solid state analysis to certify and release pharmaceutical products.

Scale indicator6 records

Each record includes

Type, Value, Description, Source

Partnership3 partners
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2022-05-31
Description

Manufacturing Development Agreement for BrYet's lead product candidate ML-016 against lung and liver metastases from breast cancer. NerPharMa to scale-up drug substance manufacturing process and finished product to supply material for clinical programs with potential for future world-wide commercial sales.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2021-05-06
Description

Partnership Agreement with ICROM srl for collaboration on commercial production of High Potent drugs and ADC-Payload. The agreement outlines sharing of technologies, know-how, facilities and workforce to offer API development and formulated drug production services to third-party companies in strategic sectors of oncology and neurology.

3Xspray Pharma
Strategic tierCoreTypeStrategic or Co-development Partner
Description

Third-party manufacturing partner for Xspray's Dasynoc (leukemia drug). NerPharMa serves as the manufacturing site where FDA identified unresolved manufacturing concerns leading to Complete Response Letter. Xspray plans to resubmit with additional commercial-scale batch data.

fiercepharma.com
Recent move7 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Italian CDMO focused on high-potency oncology manufacturing, including HP-APIs, antibody-drug conjugates, and sterile injectable manufacturing. Comparable in scale, geography, and oncology specialization to NerPharMa.

2Olon S.p.A.
TypeDirect peer
Description

Italian-headquartered global API CDMO with strong generic and oncology API manufacturing capabilities, including high-potency compounds. Directly comparable as an Italian small-molecule CDMO serving pharma clients.

TypeDirect peer
Description

European CDMO offering HP-API, injectable, and oral solid dose manufacturing, including high-potency containment. Comparable in technical capabilities and customer base to NerPharMa.

TypeDirect peer
Description

Global CDMO with significant high-potency API and sterile injectable manufacturing capabilities, including oncology assets. Comparable in scale and oncology-focused service offering to NerPharMa.

TypeBroad incumbent
Description

Large global CDMO (now owned by Novo Holdings) offering broad HP-API, sterile injectable, and oral solid dose capabilities across multiple therapeutic areas. Overlaps with NerPharMa in oncology and HP manufacturing but serves a much wider portfolio.

TypeBroad incumbent
Description

World's largest CDMO with extensive HP-API, biologics, and small-molecule manufacturing capabilities. Competes with NerPharMa in oncology API and drug product but at vastly greater scale and geographic reach.

TypeRegional player
Description

European-headquartered CDMO focused on solid oral dosage forms, sterile liquids, and HP compounds. Comparable to NerPharMa's drug product services and shares a European pharma client base.

8FAREVA
TypeRegional player
Description

French-headquartered CDMO with API, sterile injectable, and topical manufacturing capabilities across Europe. Comparable as a European mid-sized CDMO serving pharma customers.

TypeDirect peer
Description

European CDMO (formerly Farmabios, acquired by Avista Capital) specializing in HP-API and complex small-molecule manufacturing, including oncology. Comparable in technical scope and target customer base to NerPharMa.

TypeBroad incumbent
Description

European API manufacturer (Sanofi spinoff) producing small-molecule APIs across multiple therapeutic areas, including complex chemistry. Comparable in CDMO API services but with broader scope and public-company scale.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers6 records

Each record includes

Name, Industry, Type, Use case, Source, UUID

Segment2 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature5 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles6 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
Compliance8 records

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

NerPharMa

Pharmaceutical Contract Manufacturing Services (CDMO)nerpharma.com

NerPharMa firmographics

Firmographics
Name
NerPharMa
Legal name
Nerpharma S.r.l
Website
https://nerpharma.com
Company type
Private
Founded year
2010
Operating status
Operating
Headcount range
51–100 employees
Ownership category
akta.pro rank

NerPharMa industry classification

Industry
Product category
Pharmaceutical Contract Manufacturing Services (CDMO)
NAICS
Pharmaceutical and Medicine Manufacturing (32541), Pharmaceutical and Medicine Manufacturing (3254)
SIC
Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)
akta.pro industry
PRIMARYHLAGABAB
Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Development & Manufacturing Organizations (CDMO)
SECONDARYHLAGABAA
Small-Molecule API & Intermediates CDMO
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Development & Manufacturing Organizations (CDMO)
SECONDARYHLAGABAK
Clinical Trial Material (CTM) Manufacturing & Supply CDMO
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Development & Manufacturing Organizations (CDMO)
SECONDARYHLAGAHAM
Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC)
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/API & Small-Molecule Development/Manufacturing Services
SECONDARYHLAGAHAL
GMP Scale-Up, Tech Transfer & Process Validation (PPQ)
Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/API & Small-Molecule Development/Manufacturing Services

Keywords

  • Contract pharmaceutical manufacturing
  • Oncology drug development
  • Active pharmaceutical ingredients
  • Sterile injectable manufacturing
  • High potency manufacturing

Where NerPharMa is headquartered

Location

Headquarters

HQ city
Nerviano
HQ country
Italy
HQ region
Europe

Offices1 record

Markets served

NerPharMa business model

Business model
GTM type
B2B
Offering type
Services
Cost components
Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain, Marketing or Sales

Revenue model

  1. Contract Development and Manufacturing Services: NerPharMa generates revenue through providing GMP-compliant contract manufacturing services for pharmaceutical active ingredients (API/drug substance) and finished pharmaceutical products (drug product). Services include development and scale-up, regulatory support, clinical supply, and analytical services. The company operates as a CDMO with both DS and DP divisions serving global pharmaceutical clients.

Pricing tiers

ModelBillingPrice
Other—Contract-based manufacturing services for pharmaceutical companies

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

NerPharMa product offering

Product offering

Core offering

NerPharMa is a Contract Development and Manufacturing Organization (CDMO) specializing in oncology, operating two divisions—NerPharMa DS (Drug Substance) for high-potency active pharmaceutical ingredient (API) manufacturing including Protein Kinase Inhibitors and cytotoxic/cytostatic compounds, and NerPharMa DP (Drug Product) for injectable products (solutions, suspensions, lyophilized) and oral solid products (tablets, capsules). The company provides integrated services including API development and scale-up, contract manufacturing, clinical supply, regulatory support, and analytical services for global pharmaceutical and biotechnology clients.

Product overview

NerPharMa operates as a Contract Development and Manufacturing Organization (CDMO) specializing in oncology, with two core divisions: NerPharMa DS (Drug Substance) and NerPharMa DP (Drug Product). NerPharMa DS develops and manufactures active pharmaceutical ingredients exclusively for oncology (Protein Kinase Inhibitors, cytotoxic/cytostatic compounds) from laboratory to commercial scale. NerPharMa DP supports development and production of injectable products (solutions, suspensions, lyophilized products) and oral solid products (tablets, capsules). The company offers integrated services including development and scale-up, contract manufacturing, regulatory services, clinical supply, and analytical services. The company has over 15 products on the market, with unique innovative technologies including dual chamber bags and HyNap nanoparticle technology.

Differentiator

Problem solved

Functional benefit

Products and services

  • NerPharMa DS (Drug Substance) Manufacturing Development and manufacturing of active pharmaceutical ingredients (APIs) exclusively for oncology applications including Protein Kinase Inhibitors, cytotoxic and cytostatic compounds, from laboratory scale to commercial production under cGMP with multi-regulatory approval (FDA, EMA, AIFA, ANVISA Brazil, China FDA, PMDA Japan, Russia).
  • NerPharMa DP (Drug Product) Manufacturing Contract development and production of injectable products (solutions, suspensions, and lyophilized products) and oral solid products (tablets and capsules) for various therapeutic areas, handling Protein Kinase Inhibitors, cytotoxic and cytostatic products, with formulation, packaging, and distribution activities. Authorized by AIFA for medicinal product manufacture and packaging.
  • Development and Scale-up Services Full support from API synthetic route development through formulation, process development, analytical methods, scale-up, technology transfer, regulatory filing support, and commercial manufacturing for pharmaceutical clients.
  • Regulatory Services Guidance and consulting in IMPD, IND, DMF, CMC and dossier preparation and filing, with CMC section support for IND, NDA, and ANDA filings across the EU, US, and Japan for pharmaceutical clients.
  • Clinical Supply Services Manufacturing, labeling, packaging, and distribution of investigational medicinal products from laboratory to production scale for Phase 1 through Phase 4 clinical studies, including patient kit assembly combining primary and associated drug products.
  • Analytical Services Comprehensive analytical testing including method development and validation, ICH stability studies, dissolution profiles, impurity characterization, and full solid state analysis to certify and release pharmaceutical products.

Quantifiable outcome

  • More than 15 products successfully commercialized
  • +2 more outcomes

Companies that use NerPharMa

Customer profile

Named customers6 records

Segments2 records

Ideal customer profiles2 records

NerPharMa technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature5 records

NerPharMa partnerships and signals

Strategic signal

Partnerships

Three partnerships are on record, tiered core.

  • BrYet Health InccoreStrategic or Co-development Partner · 31 May 2022Manufacturing Development Agreement for BrYet's lead product candidate ML-016 against lung and liver metastases from breast cancer. NerPharMa to scale-up drug substance manufacturing process and finished product to supply material for clinical programs with potential for future world-wide commercial sales.
  • ICROM srlcoreStrategic or Co-development Partner · 6 May 2021Partnership Agreement with ICROM srl for collaboration on commercial production of High Potent drugs and ADC-Payload. The agreement outlines sharing of technologies, know-how, facilities and workforce to offer API development and formulated drug production services to third-party companies in strategic sectors of oncology and neurology.
  • Xspray PharmacoreStrategic or Co-development PartnerThird-party manufacturing partner for Xspray's Dasynoc (leukemia drug). NerPharMa serves as the manufacturing site where FDA identified unresolved manufacturing concerns leading to Complete Response Letter. Xspray plans to resubmit with additional commercial-scale batch data.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

NerPharMa competitors and assessment

Company assessment

Direct peers

  • BSP Pharmaceuticals: Italian CDMO focused on high-potency oncology manufacturing, including HP-APIs, antibody-drug conjugates, and sterile injectable manufacturing. Comparable in scale, geography, and oncology specialization to NerPharMa.
  • Olon S.p.A. Italian-headquartered global API CDMO with strong generic and oncology API manufacturing capabilities, including high-potency compounds. Directly comparable as an Italian small-molecule CDMO serving pharma clients.
  • Corden Pharma: European CDMO offering HP-API, injectable, and oral solid dose manufacturing, including high-potency containment. Comparable in technical capabilities and customer base to NerPharMa.
  • Piramal Pharma Solutions: Global CDMO with significant high-potency API and sterile injectable manufacturing capabilities, including oncology assets. Comparable in scale and oncology-focused service offering to NerPharMa.
  • Axplora: European CDMO (formerly Farmabios, acquired by Avista Capital) specializing in HP-API and complex small-molecule manufacturing, including oncology. Comparable in technical scope and target customer base to NerPharMa.

Broad incumbents

  • Catalent: Large global CDMO (now owned by Novo Holdings) offering broad HP-API, sterile injectable, and oral solid dose capabilities across multiple therapeutic areas. Overlaps with NerPharMa in oncology and HP manufacturing but serves a much wider portfolio.
  • Lonza: World's largest CDMO with extensive HP-API, biologics, and small-molecule manufacturing capabilities. Competes with NerPharMa in oncology API and drug product but at vastly greater scale and geographic reach.
  • EuroAPI: European API manufacturer (Sanofi spinoff) producing small-molecule APIs across multiple therapeutic areas, including complex chemistry. Comparable in CDMO API services but with broader scope and public-company scale.

Regional players

  • Aenova: European-headquartered CDMO focused on solid oral dosage forms, sterile liquids, and HP compounds. Comparable to NerPharMa's drug product services and shares a European pharma client base.
  • FAREVA: French-headquartered CDMO with API, sterile injectable, and topical manufacturing capabilities across Europe. Comparable as a European mid-sized CDMO serving pharma customers.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

NerPharMa social profiles

Digital presence

NerPharMa compliance and trust

Trust signal

Compliance8 records

NerPharMa financial estimates

Financial estimate

Revenue estimate

Valuation estimate

NerPharMa leadership team

Management profile

Number of profiles

Profiles6 records

NerPharMa funding detail

Funding detail

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

NerPharMa M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about NerPharMa

What does NerPharMa do?

NerPharMa is a Contract Development and Manufacturing Organization (CDMO) specializing in oncology, operating two divisions—NerPharMa DS (Drug Substance) for high-potency active pharmaceutical ingredient (API) manufacturing including Protein Kinase Inhibitors and cytotoxic/cytostatic compounds, and NerPharMa DP (Drug Product) for injectable products (solutions, suspensions, lyophilized) and oral solid products (tablets, capsules). The company provides integrated services including API development and scale-up, contract manufacturing, clinical supply, regulatory support, and analytical services for global pharmaceutical and biotechnology clients.

Is NerPharMa a public or private company?

NerPharMa is a private company. It is classified as corporate owned and is currently operating.

When was NerPharMa founded?

NerPharMa was founded in 2010. It employs 51 to 100 people.

Where is NerPharMa based?

NerPharMa is headquartered in Nerviano, Italy, in the Europe region.

How does NerPharMa make money?

One revenue line is on record: contract Development and Manufacturing Services.

Who are NerPharMa's main competitors?

Direct peers on record are BSP Pharmaceuticals, Olon S.p.A., Corden Pharma, Piramal Pharma Solutions and Axplora. Broad incumbents are Catalent, Lonza and EuroAPI. Regional players are Aenova and FAREVA.

Does NerPharMa have an API?

No public API is recorded for NerPharMa.

What industry is NerPharMa in?

NerPharMa's product category is Pharmaceutical Contract Manufacturing Services (CDMO). Its primary akta.pro industry code is HLAGABAB, Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO, with a secondary code of HLAGABAA, Small-Molecule API & Intermediates CDMO. Its NAICS code is 32541 and its SIC code is 2834.

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Live signals
FinancialContent Business PageBrYet Announces AIFA Approval of First-In-Kind cGMP Manufacturing Line for ML-016, Enabling Imminent Clinical Supply to AustraliaBrYet announced AIFA approval of a first-in-kind cGMP manufacturing line for its lead cancer drug ML-016, enabling clinical supply to Australia. The line, built with NerPharMa, was produced to Australian regulatory specifications, with shipment expected shortly. The company has Australian approval to begin its first-in-human trial, with the first patient dose expected in late 2026.MorningstarBrYet Announces AIFA Approval of First-In-Kind cGMP Manufacturing Line for ML-016, Enabling Imminent Clinical Supply to AustraliaBrYet announced AIFA approval of a first-in-kind cGMP manufacturing line for ML-016, its lead cancer therapeutic. The approval enables production of clinical-grade drug product for an upcoming Australian clinical trial, with shipment expected shortly. The company has received Australian approval to begin the first-in-human study, with the first patient dose expected in late 2026.MarketScreenerXspray updates on FDA processesXspray requested a Type A meeting with the FDA for Nilopki and a Type C meeting for Dasynoc, both pending contract manufacturer NerPharMa's CGMP status. The FDA is reviewing Dasynoc's labeling ahead of its August 25 PDUFA date, while Nilopki's clinical data and stability program face no objections.PR NewswireTrovagene Announces FDA Approval of IND for Phase 1b/2 Trial of PCM-075 in Patients with Acute Myeloid LeukemiaTrovagene, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for PCM-075, a Polo-like Kinase 1 (PLK1) inhibitor, authorizing the company to proceed with a Phase 1b/2 clinical trial in patients with acute myeloid leukemia (AML). The trial will be conducted at The University of Texas MD Anderson Cancer Center under principal investigator Dr. Jorge Eduardo Cortes, with approximately 60 patients expected to be dosed in the dose-escalation and continuation phases. PCM-075 will be manufactured by NerPharMa, a subsidiary of Nerviano Medical Sciences, and administered orally in combination with decitabine over 28-day cycles.