The Daily Biotech Pulse: Lilly Strikes $1.6B R&D Collaboration, FSD Pulls Plug On COVID-19 Program, Cassava Sinks On Questions About Alzheimer's Drug

ere's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 24)

• Agenus Inc. AGEN
• Bio-Rad Laboratories, Inc. BIO
• Celldex Therapeutics, Inc. CLDX
• Dynavax Technologies Corporation DVAX (reacted to the Taiwanese rollout of Medigen's MVC-COV1901 COVID-19 vaccine that uses the company's adjuvant)
• Masimo Corporation MASI
• Medtronic plc MDT (reacted to quarterly results)
• MiMedx Group, Inc. MDXG
• Monte Rosa Therapeutics, Inc. GLUE
• Nuvalent, Inc. NUVL (IPOed July 29)
• Repligen Corporation RGEN
• ShockWave Medical, Inc. SWAV
• Tenaya Therapeutics, Inc. TNYA (IPOed July 30)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 24)

• Oyster Point Pharma, Inc. OYST
• Sonnet BioTherapeutics Holdings, Inc. SONN
• Theravance Biopharma, Inc. TBPH (announced its ulcerative colitis treatment candidate flunked a mid-stage study)
• VectivBio Holding AG VECT

Stocks In Focus

FSD Stops Mid-stage COVID-19 Treatment Study Following Determination that It Isn't Commercial Viable

FSD Pharma, Inc. HUGE announced that it intends to terminate the Phase 2 clinical trial of ultra-micronized palmitoylethanolamide or FSD-201, for use in treating COVID-19.

Following the review of the commercial viability of the program, the company concluded that, while there are potential commercial opportunities for FSD-201, specifically the treatment of COVID-19 by FSD-201 is unlikely to be commercially viable. Based on this information, the company has elected to terminate the current Phase 2 clinical study in order to concentrate its resources on more commercially viable opportunities.

The stock was losing 12.79% to $1.50 in premarket trading.

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

argenx's Efgartigimod Accepted For Regulatory Review In Europe as a Treatment Option For Neuromuscular Disorder

argenx SE ARGX announced that it has submitted, and the European Medicines Agency has validated, the marketing authorization application for the its investigational FcRn antagonist, efgartigimod, for the treatment of generalized myasthenia gravis.

Validation of the MAA confirms that the application is sufficiently complete to begin the formal review process.

The stock was up 1.12% at $347.11 in premarket trading.

Eagle Pharma to In-license Pneumonia Drug From Swiss Biopharma Combioxin

Eagle Pharmaceuticals, Inc. EGRX said it has entered into a worldwide licensing agreement with Combioxin SA, a clinical-stage Swiss biotech, for the commercial rights to CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe pneumonia in combination with traditional antibacterial drugs.

Under the Agreement, Eagle will be solely responsible for further clinical development of CAL02 and will make an upfront payment, followed by additional payments upon achievement of development milestones, regulatory approval and based upon commercial sales. Eagle expects to invest $35 million to achieve interim results. These interim results are expected in the first half of 2023.

The company sees CAL02 possessing potential to address significant unmet need in the treatment of severe pneumonia, which accounts for 2.4 million deaths per year globally. It also anticipates ten years of regulatory exclusivity.

Lilly Strikes Targeted Therapy Drug Development Collaboration With Lycia For Up to $1.6B

Eli Lilly and Company LLY and Lycia Therapeutics, Inc. announced a multi-year R&D and licensing agreement focused on the discovery, development and commercialization of novel targeted therapeutics using Lycia's platform technology.

Under the terms of the agreement, the companies will utilize Lycia's LYTAC platform to discover and develop novel degraders for up to five targets that aim to address key unmet medical needs in Lilly's therapeutic areas of focus, including immunology and pain. Lilly will be solely responsible for preclinical and clinical development of candidates and receives an exclusive worldwide license to commercialize potential medicines resulting from the agreement.

Lycia will receive an upfront payment of $35 million. The company is also eligible to receive over $1.6 billion in potential milestone payments based on the achievement of prespecified preclinical, development and commercial milestones, as well as tiered royalties from mid-single to low double-digits on sales resulting from the agreement.

Cassava Sciences Refutes Allegation Regarding its Alzheimer's Drug

Cassava Sciences, Inc. SAVA issued a response to claims that were posted on-line yesterday after market hours, which said it believes the claims made in this post regarding scientific integrity are false and misleading. The company also said it stands behind its science, its scientists and its scientific collaborators, and is responding to ensure the facts are known and respected.

The stock was down 17.68% at $97 in premarket trading.

Novartis' Asciminib NDA Accepted For Priority Review By FDA

Novartis AG NVS said the Food and Drug Administration accepted and granted priority review to the company's new drug application for asciminib in chronic myeloid leukemia, following its submission under the FDA's ‘Real-Time Oncology Review' program.

Merck's Pneumococcal VaccineFound Effective In Infants

Merck & Co., Inc. MRK announced positive topline results from the pivotal PNEU-PED study evaluating the immunogenicity, safety and tolerability of Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in healthy infants enrolled between 42-90 days of age.

The vaccine met the primary endpoints of non-inferior to PCV13 for all 13 shared serotypes 30 days after the third dose as well as 30 days after the fourth dose.

Lipocine Reports Positive Positive Results For Proof-of-concept Phase 2 NASH Study

Lipocine Inc. LPCN announced positive topline 36-week results from its Phase 2 proof of concept clinical study, NCT04134091, investigating LPCN 1144 in men with biopsy-confirmed non-alcoholic steatohepatitis.

LPCN 1144 comprises an orally delivered prodrug of endogenous testosterone.

"At 12 weeks, treatments with LPCN 1144 resulted in statistically significant liver fat reduction, assessed by MRI-PDFF, meeting the pre-specific primary endpoint of the LiFT clinical study," the company said.

The stock was down 2.13% at $1.38 in premarket trading.

On The Radar

Clinical Readouts

Amneal Pharmaceuticals, Inc. AMRX will announce after the market close, initial data from pivotal Phase 3 study of IPX-203 in patients with Parkinson's disease who experience motor fluctuations.

Aileron Therapeutics, Inc. ALRN will release at the International Society for Experimental Hematology meeting final data from the completed Phase 1b trial of ALRN-6924 in patients with small cell lung cancer and initial findings from ongoing healthy volunteer Study of ALRN-6924.

Earnings

Ascendis Pharma A/S ASND (after the close)