The Daily Biotech Pulse: Sanofi-GlaxoSmithKline To Supply 200M Doses To COVID-19 Vaccine Alliance, Gilead Earnings, Biodesix Debuts

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 Oct. 27)

• Amicus Therapeutics, Inc. (NASDAQ: FOLD)

• Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)

• Ascendis Pharma A/S (NASDAQ: ASND)

• BioLife Solutions Inc (NASDAQ: BLFS)

• Bio-Rad Laboratories, Inc. (NYSE: BIO)

• Denali Therapeutics Inc (NASDAQ: DNLI)

• EXACT Sciences Corporation (NASDAQ: EXAS) ( announced two acquisitions and also reported better-than-expected Q3 revenues)

• Guardant Health Inc (NASDAQ: GH)

• Kodiak Sciences Inc (NASDAQ: KOD)

• Repligen Corporation (NASDAQ: RGEN)

• Spruce Biosciences Inc (NASDAQ: SPRB)

• Stoke Therapeutics Inc (NASDAQ: STOK)

• Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 27)

• Avenue Therapeutics Inc (NASDAQ: ATXI)

• Baudax Bio Inc (NASDAQ: BXRX)

• Biogen Inc (NASDAQ: BIIB)

• Biondvax Pharmaceuticals Ltd – ADR (NASDAQ: BVXV)

• Catabasis Pharmaceuticals Inc (NASDAQ: CATB) (announced failed late-stage trial of its investigational asset for Duchenne muscular dystrophy)

• DBV Technologies ADR Representing 0.5 Ord Shs (NASDAQ: DBVT)

• Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT)

• Foghorn Therapeutics Inc (NASDAQ: FHTX) (IPOed Friday)

• FSD Pharma Inc (NASDAQ: HUGE)

• Jaguar Health Inc (NASDAQ: JAGX)

• Kiromic Biopharma Inc (NASDAQ: KRBP)

• Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX)

• Metacrine Inc (NASDAQ: MTCR)

• Opiant Pharmaceuticals Inc (NASDAQ: OPNT)

• Psychemedics Corp. (NASDAQ: PMD)

• Recro Pharma Inc (NASDAQ: REPH)

• Rockwell Medical Inc (NASDAQ: RMTI)

• Royalty Pharma plc (NASDAQ: RPRX)

• Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)

• Tricida Inc (NASDAQ: TCDA)

• X4 Pharmaceuticals Inc (NASDAQ: XFOR)

• Zosano Pharma Corp (NASDAQ: ZSAN)

Stocks In Focus Lilly Strikes Collaboration With Swiss Biotech Basilea In Stomach Cancer Study

Eli Lilly And Co (NYSE: LLY) and Swiss biopharma Basilea Pharmaceutica announced a clinical trial collaboration and supply agreement for the use of the former's anti-VEGFR2 antibody ramucirumab in the ongoing multi-cohort phase 1/2 study with the FGFR inhibitor derazantinib in advanced gastric cancer patients with FGFR genetic aberrations. Basilea is the sponsor of the study, while Lilly will collaborate on clinical aspects and provide clinical supply of ramucirumab, the companies said.

Separately, Lilly announced an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab, 700 mg, an investigational neutralizing antibody, for $375 million. The company has submitted a request for an emergency use authorization for bamlanivimab for the treatment of mild to moderate COVID-19 in high-risk patients to the FDA in early October.

The initial agreement is for delivery over the two months following an EUA and also provides the option for the U.S. government to purchase up to an additional 650,000 vials through June 30, 2021, under the same terms as the base agreement.

Sanofi, GlaxoSmithKline To Supply 200M Doses of Coronavirus Vaccine to COVAX Global Alliance

Sanofi SA (NASDAQ: SNY) and GlaxoSmithKline plc (NYSE: GSK) signed a statement of intent with Gavi, the legal administrator of the COVAX Facility, to supply 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities and subject to contract, to the COVAX Facility.

COVAX Facility is a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines.

Updating on the status of the vaccine program, the companies said the first results from the Phase 1/2 study initiated in early September is expected in early December. This will support the initiation of a pivotal Phase 3 study before the end of the year, they added.

If these data are sufficient for licensure application, the companies plan to request regulatory approval from the first half of 2021.

Novartis Announces In-Licensing Agreement For COVID-19 Treatment Candidates

Novartis AG (NYSE: NVS) announced an option and license agreement with Swiss biotech Molecular Partners to develop the latter's anti-COVID-19 DARPin program, consisting of two therapeutic candidates, MP0420 and MP0423.

Under the agreement, during the option period, Molecular Partners will conduct Phase 1 clinical trials for MP0420, which is set to start in November 2020, and perform all remaining preclinical work for MP0423.

Subsequently, Novartis will conduct Phase 2 and Phase 3 clinical trials, with Molecular Partners as sponsor of these trials. Upon option exercise, Novartis would be responsible for all further development and commercialization activities.

View more earnings on IBB

The financial terms of the agreement call for Novartis paying an upfront payment of 60 million francs ($66 million), including equity, and a further 150 million francs ($165 million), upon it choosing to exercise options for both therapeutic candidates.

Neovasc Sinks On Negative FDA Panel Vote On Medical Device to Treat Refractory Angina

Neovasc Inc (NASDAQ: NVCN) said FDA's Circulatory System Devices Advisory Panel voted 14 to 4 in favor that the Neovasc Reducer is safe when used as intended, and voted 1 to 17 against on the issue of a reasonable assurance of effectiveness. The third vote was 13 to 3 against on whether the relative benefits outweighed the relative risks.

The Reducer is currently under review by the agency for treatment of patients with refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.

In premarket trading Wednesday, Neovasc shares were slumping 34.97% to $1.19.

miRagen Acquires Viridian Therapeutics, To Raise $91M From a Private Placement

miRagen Therapeutics Inc (NASDAQ: MGEN) announced it has completed the acquisition of Viridian Therapeutics, Inc., a privately held biotechnology company, in an all stock deal.

Concurrent with the acquisition of Viridian, miRagen said entered into a definitive agreement for the sale of Series A non-voting convertible preferred stock in a private placement to a group of institutional accredited investors to raise $91 million in gross proceeds.

miRagen shares were jumping 67.34% to 87 cents.

Allakos Pre-announces Wider Q3 Loss, to Offer $250M Common Stock

Allakos Inc (NASDAQ: ALLK) pre-announced third-quarter results, expecting a wider loss of $40 million to $50 million compared to a loss of $21.7 million in the year-ago period.

The company estimates that cash, cash equivalents and investments in marketable securities will be $419.8 million as of September 30, 2020.

Separately, the company said it intends to offer $250 million of shares of its common stock in an underwritten public offering. All of the shares in the proposed offering will be sold by the company.

Aurinia's Lead Drug Candidate to Be Evaluated In Kidney Transplant Recipients With COVID-19

Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) announced the funding and initiation of an open-label exploratory trial, dubbed the VOCOVID study, evaluating the antiviral effects of voclosporin in kidney transplant recipients with COVID-19.

The single-center, investigator-initiated trial is being conducted at the Leiden University Medical Center in the Netherlands and will compare voclosporin against tacrolimus, Aurinia said.

On The Radar Earnings

Integra Lifesciences Holdings Corp (NASDAQ: IART) (before the market open)
United Therapeutics Corporation (NASDAQ: UTHR) (before the market open)
PPD Inc (NASDAQ: PPD) (before the market open)
Boston Scientific Corporation (NYSE: BSX) (before the market open)
Aethlon Medical, Inc. (NASDAQ: AEMD) (after the close)
Amgen, Inc. (NASDAQ: AMGN) (after the close)
Alimera Sciences Inc (NASDAQ: ALIM) (after the close)
Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (after the close)
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (after the close)
Globus Medical Inc (NYSE: GMED) (after the close)
Gilead Sciences, Inc. (NASDAQ: GILD) (after the close)
Merit Medical Systems, Inc. (NASDAQ: MMSI) (after the close)
Penumbra Inc (NYSE: PEN) (after the close)
Viking Therapeutics Inc (NASDAQ: VKTX) (after the close)
GenMark Diagnostics, Inc (NASDAQ: GNMK) (after the close)

IPOs

Boulder, Colorado-based Biodesix, Inc., a data-driven diagnostic solutions company, priced its downsized initial public offering of 4 million shares at $18 apiece compared to the estimated price range of $17-$19. The company's shares will begin trading on the Nasdaq under the ticker symbol BDSX.

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