The Daily Biotech Pulse: Pfizer In Vaccine Supply Talks With India, Provention In Focus Ahead Of Briefing Doc, NeuroRx To List Via SPAC Deal

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs May 24)

• Bristol-Myers Squibb Company BMY
• ESSA Pharma Inc. EPIX
• Horizon Therapeutics Public Limited Company HZNP
• Intra-Cellular Therapies, Inc. ITCI
• Jazz Pharmaceuticals plc JAZZ
• Novo Nordisk A/S NVO
• PDS Biotechnology Corporation PDSB
• PLx Pharma Inc. PLXP
• PRA Health Sciences, Inc. PRAH
• Renalytix AI plc RNLX
• ShockWave Medical, Inc. SWAV
• Verastem, Inc. VSTM (announced breakthrough designation for combo therapy in ovarian cancer)
• West Pharmaceutical Services, Inc. WST
• Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 24)

• 4D Molecular Therapeutics, Inc. FDMT
• Adverum Biotechnologies, Inc. ADVM
• Amicus Therapeutics, Inc. FOLD
• Atreca, Inc. BCEL
• Black Diamond Therapeutics, Inc. BDTX
• Coherus BioSciences, Inc. CHRS
• Evoke Pharma, Inc. EVOK
• Homology Medicines, Inc. FIXX
• Impel NeuroPharma, Inc. IMPL
• Intercept Pharmaceuticals, Inc. ICPT
• Kiniksa Pharmaceuticals, Ltd. KNSA
• LogicBio Therapeutics, Inc. LOGC
• Nymox Pharmaceutical Corporation NYMX
• Sigilon Therapeutics, Inc. SGTX

Stocks In Focus

Tiziana Commences Study Of Nasal Foralumab In Secondary Progressive Multiple Sclerosis

Tiziana Life Sciences plc TLSA said the first patient with secondary progressive multiple sclerosis was dosed with nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, at the Brigham and Women's Hospital, Harvard Medical School, Boston, under an individual patient expanded access program.

Nasal Foralumab 50 mcg will be administered in three-week cycles, with three times/week dosing for the first two weeks followed by one week of rest.

The company said the treatment regimen will continue for six months to examine long-term safety, tolerability and clinical responses.

TLC's Antifungal Treatment Gets Approval In India

Taiwan Liposome Company, Ltd. TLC said the Central Drugs Standard Control Organization of India has approved the new drug application of Amphotericin B Liposome for Injection 50mg, for immediate importation per approved usage and indication, to aid in the country's emergency of acute liposomal amphotericin B shortage.

AmphoTLC is a liposomal amphotericin B injection indicated for severe systemic fungal infections such as mucormycosis.

The stock was up 7.36% to $5.25 in premarket trading Tuesday.

Provention Bio In Focus Ahead Of Release Of Briefing Document

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on Thursday to discuss Provention Bio, Inc.'s PRVB BLA for teplizumab intravenous infusion, for the delay or prevention of clinical type 1 diabetes mellitus in at-risk individuals.

The FDA will release a briefing document prepared by FDA staffers that will provide background and other information for deliberation by the FDA panel.

Incidentally, the company communicated in early April the FDA warned of deficiencies in the regulatory application, deeming that the pharmacokinetic profiles of the company's candidate and Eli Lilly and Company's LLY original drug substance used in the bridging study are not comparable.

The stock was down 1.63% at $7.85 in after-hours trading.

AnPac To Set Up Joint Venture For Developing Cancer Treatment Technologies, Products

AnPac Bio-Medical Science Co., Ltd. ANPC announced that on May 17, its board of directors approved the establishment of a joint venture, together with its founder and chairman, Dr. Chris Chang Yu, and certain other individuals to develop a new cancer treatment technology and associated products.

AnPac Bio will contribute two filed patent applications in the space of cancer treatment to the venture, and shareholding percentages of AnPac Bio and other shareholders will be determined based on the value of the patent applications assessed by an independent appraisal firm, as well as other commercial factors.

The stock was rallying 31.62% to $6.16 in premarket trading Tuesday.

Related Link: The Week Ahead In Biotech (May 23-29): Eton, Lantheus FDA Decisions, Adcom Test For Provention, Chiasma Data Presentation

Exelixis Announces Positive Phase 1b Study Of Cabometyx Combo Therapy In Prostate Cancer

Exelixis, Inc. EXEL announced results from the metastatic castration-resistant prostate cancer cohort 6 of COSMIC-021, the phase 1b trial of cabozantinib in combination with Roche Holding AG's RHHBY Tecentriq in patients with locally advanced or metastatic solid tumors, showing objective response rates of 27% and 18% per investigator assessment and Blinded Independent Radiology Committee, respectively.

Cohort 6 included patients with metastatic CRPC who had been previously treated with enzalutamide and/or abiraterone acetate.

Exelixis said it intends to discuss the results with the FDA to determine next steps toward a regulatory submission for the combination regimen for patients with high-risk metastatic CRPC.

Pfizer In Talks With India To Supply COVID-19 Vaccine, Reuters Reports

Pfizer, Inc. PFE is in talks with the Indian government to supply the COVID-19 vaccine, it jointly developed with Germany's BioNTech SE BNTX, Reuters reported.

"Pfizer remains committed to continuing our engagement with the government of India towards making the Pfizer BioNTech Covid-19 vaccine available for use in the country," the report said, citing a Pfizer spokesperson.

Pfizer shares were edging up 0.18% to $39.88 in premarket trading Tuesday.

Liquidia Says Generic Pulmonary Arterial Hypertension Drug Available For Subcutaneous Administration Using Cartridge Developed By Its Partner

Liquidia Corporation LQDA said Novartis AG's NVS Sandoz unit's Treprostinil Injection, a generic form of Remodulin, is now also available for subcutaneous administration to treat patients diagnosed with pulmonary arterial hypertension.

Sandoz Treprostinil Injection was the first fully-substitutable AP rated generic version of Remodulin, which is being marketed by United Therapeutics Corporation UTHR.

Liquidia's manufacturing partner Chengdu Shifeng Medical Technologies began selling the RG 3ml Medication Cartridge, which may be used to supply medications to PAH patients. Liquidia had previously announced the FDA's clearance of Chengdu's 510(k) supporting the use of the cartridge with the CADD-MS 3 pump manufactured by Smiths Medical, which has been used for the SC administration of Remodulin for more than 10 years.

Liquidia shares were up 2.57% at $3.90 in after-hours trading.

On The Radar

Clinical Readouts/Presentations

Novavax, Inc.'s NVAX R&D president Gregory Glenn will present on NVX-CoV2373, the company's recombinant nanoparticle COVID-19 vaccine candidate, during the 2021 International Society for Vaccines Virtual Congress 6th COVID-19 Vaccine Update.

Earnings

Burning Rock Biotech Limited BNR (before the market open)

Trinity Biotech plc TRIB (before the market open)

IPOs

NeuroRx, Inc., announced its shares have been approved for listing on the Nasdaq following the completion of its business combination with Big Rock Partners Acquisition Corp. BRPA. The combined entity is NRx Pharmaceuticals, Inc. and will trade on the Nasdaq Global Market as NRXP.

NeuroRx is a patient-focused, clinical stage pharmaceutical company that focuses on developing therapies to treat diseases where no medicines currently exist.

Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates