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The Daily Biotech Pulse: Amarin Surges On Vascepa Data, Mesoblast Rallies On Novartis Deal, Decision Day For Eiger

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The Daily Biotech Pulse: Amarin Surges On Vascepa Data, Mesoblast Rallies On Novartis Deal, Decision Day For Eiger

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 Nov. 19)

  • Aligos Therapeutics Inc (NASDAQ: ALGS)
  • ALX Oncology Holdings Inc (NASDAQ: ALXO)
  • Atara Biotherapeutics Inc (NASDAQ: ATRA)
  • China Biologic Products Holdings Inc (NASDAQ: CBPO) (announced a go-private transaction)
  • Corcept Therapeutics Incorporated (NASDAQ: CORT) (announced a ruling upholding the validity of all claims of U.S. Patent No. 10,195,214)
  • Idera Pharmaceuticals Inc (NASDAQ: IDRA)
  • Infinity Pharmaceuticals Inc. (NASDAQ: INFI)
  • Pacira Biosciences Inc (NASDAQ: PCRX)
  • Prelude Therapeutics Inc (NASDAQ: PRL)
  • Replimune Group Inc (NASDAQ: REPL)
  • Rocket Pharmaceuticals Inc (NASDAQ: RCKT)
  • Spruce Biosciences Inc (NASDAQ: SPRB)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON)
  • Travere Therapeutics, Inc. (RTRX)
  • Trillium Therapeutics Inc (NASDAQ: TRIL)
  • Twist Bioscience Corp (NASDAQ: TWST)
  • Urovant Sciences Ltd (NASDAQ: UROV)
  • Veracyte Inc (NASDAQ: VCYT)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Nov. 19)

  • Benitec Biopharma Inc (NASDAQ: BNTC)
  • Kiromic Biopharma Inc (NASDAQ: KRBP)
  • Polypid Ltd (NASDAQ: PYPD)

Stocks In Focus

Amarin's Late-Stage Vascepa Trial In China Meets Study Goals

Amarin Corporation plc (NASDAQ: AMRN) announced positive, statistically significant top-line results from a Phase 3 clinical trial of its fish oil pill Vascepa conducted in China by its partner, Edding. The study, which investigated Vascepa as a treatment for patients with very high triglycerides, met its primary efficacy endpoint as defined in the clinical trial protocol and demonstrated a safety profile similar to placebo, the company said.

The company said the findings are being prepared to support Edding's dossier for seeking regulatory approval of Vascepa in mainland China.

Amarin shares were jumping 18.06% to $5.36 premarket Friday.

Mesoblast Strikes Stem Cell Therapy Collaboration Agreement With Novartis

Mesoblast limited (NASDAQ: MESO) announced an exclusive worldwide license and collaboration agreement with Novartis AG (NYSE: NVSP) for the development of its mesenchymal stromal cell product remestemcel-L, with an initial focus on the development of the treatment of acute respiratory distress syndrome, including that associated with COVID-19.

The agreement provides for Novartis making a $50-million upfront payment, including $25 million in equity. Mesoblast may also receive a total of $505 million pending achievement of precommercialization milestones for ARDS indications. It could also receive additional payments post-commercialization of up to $750 million based on achieving certain sales milestones and tiered double-digit royalties on product sales.

Separately, Mesoblast reported first-quarter revenue of $1.3 million, down from $17 million in the year-ago quarter, which included $15 million in upfront milestone payment received for the strategic partnership with Grünenthal GmbH.The net loss per share widened from 1.10 cents to 4.21 cents.

The stock jumped 17.73% premarket to $13.88. 

Lilly's Drug Combo Issued Emergency Use Authorization For COVID-19

Eli Lilly And Co (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) said the FDA issued an emergency use authorization for the distribution and emergency use of baricitinib to be used in combination with Gilead Sciences, Inc.'s (NASDAQ: GILD) remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.

Baricitinib, discovered by Incyte, has been licensed to Lilly.

Separately, Lilly announced a R&D and exclusive license agreement to utilize Precision BioSciences Inc's (NASDAQ: DTIL) proprietary ARCUS genome editing platform for the R&D of potential in vivo therapies for genetic disorders, with an initial focus on Duchenne muscular dystrophy and two other undisclosed gene targets.

Lilly shares were up 0.7% premarket at $144.41, while Gilead shares were down 1.62% at $59.65.

Precision BioSciences shares were jumping 28.1% to $12.40 in premarket trading Friday.

Pfizer, BioNTech To Submit EUA For Coronavirus Vaccine Friday

Pfizer Inc. (NYSE: PFE) and BioNTech SE – ADR (NASDAQ: BNTX) confirmed that they would submit emergency use application for their coronavirus vaccine candidate to the FDA on Friday.

In premarket trading Friday, Pfizer was adding 1.6% to $36.77 and BioNTech shares were rallying 6.99% to $101.57.

Related Link: The Week Ahead In Biotech: The Vaccine Updates, Drug Presentations, And FDA Decisions That Will Move The Markets

BeiGene’s In-Licensed Osteoporosis Drug Gets Label Expansion In China

Beigene Ltd (NASDAQ: BGNE) said the China National Medical Products Administration has approved Xgeva for the prevention of skeletal-related events in patients with bone metastases from solid tumors and in patients with multiple myeloma.

Developed by Amgen, Inc. (NASDAQ: AMGN) and licensed to BeiGene in China under a strategic collaboration commenced earlier this year, Xgeva is also approved and marketed in China for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone that is unresectable or where surgical resection is likely to result in severe morbidity.

MannKind Gets Final Development Milestone Payment Of $12.5M For Hypertension Drug

MannKind Corporation (NASDAQ: MNKD) said it has achieved the final development milestone under its licensing and collaboration agreement with United Therapeutics Corporation (NASDAQ: UTHR) for the development and commercialization of a dry powder formulation of treprostinil. The fourth milestone payment fetched MannKind $12.5 million.

Treprostinil Technosphere is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension.

"We are looking forward to working with United Therapeutics during the first part of 2021 to prepare an FDA submission for TreT," said MannKind CEO Michael Castagna.

In after-hours trading, MannKind shares were up 2.54% to $2.83.

AstraZeneca's Imfinzi Approved For Additional Dosage In Lung, Bladder Cancers

AstraZeneca plc (NASDAQ: AZN) said its Imfinzi has been approved in the U.S. for an additional dosing option, a 1,500mg fixed dose every four weeks in the approved indications of unresectable Stage 3 non-small cell lung cancer after chemoradiation therapy and previously treated advanced bladder cancer.

In premarket trading Friday, the shares were up 2.07% to $55.15.

Aptevo Confirms Takeover Interest For $50/Share In Cash

Aptevo Therapeutics Inc (NASDAQ: APVO) confirmed it has received an unsolicited non-binding indication of interest from Tang Capital Partners, LP expressing its interest in acquiring all of the outstanding shares of Aptevo that it does not already own for $50 per share in cash.

While recommending that shareholders take no action at this juncture, the company said its board will carefully evaluate and consider this indication of interest in due course in the context of Aptevo's strategic plans, and its ongoing review of a broad range of opportunities to enhance stockholder value.

After jumping 29.10% to $45.69 in regular trading on the speculation, the stock was down slightly premarket at $45.65.

Affimed Reports Positive Phase 1 Results For Cancer Drug Combo

Affimed NV (NASDAQ: AFMD) announced the publication in Blood of positive results for the Phase 1b study of AFM13, a CD30/CD16A innate cell engager, in combination with Merck & Co., Inc.'s (NYSE: MRK) Keytruda.

The results demonstrate promising signs of efficacy including an objective response rate of 88% at the highest treatment dose, as well as a complete response of 46% in patients with relapsed/refractory Hodgkin lymphoma. As a monotherapy, Keytruda demonstrated an ORR of 69% and a CR of 22.4% in the KEYNOTE-087 trial.

Affimed shares were up 1.66% to $4.90 in after-hours trading.

Offerings

Avrobio Inc (NASDAQ: AVRO) said it has priced its underwritten public offering of 5 million shares of its common stock at $15 per share for raising gross proceeds of $75 million. The offering is expected to close on or about Nov. 24, subject to customary closing conditions.

The stock fell 7.13% to $15.77 in after-hours trading.

On The Radar

PDUFA Dates

Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) has a binary event with respect to its NDA for Lonfarnib in progeria and progeroid laminopathies.

Clinical Readout/Presentations

2020 Society for Neuro-Oncology Meeting Presentations:

Kazia Therapeutics Ltd (NASDAQ: KZIA): Phase 2 data for GDC-0084 in glioblastoma multiforme

Connective Tissue Oncology Society Virtual Annual Meeting Presentations

Karyopharm Therapeutics Inc (NASDAQ: KPTI): data from the Phase 3 portion of the SEAL study of Xpovio in advanced dedifferentiated liposarcoma

Cogent Biosciences Inc (NASDAQ: COGT): final clinical data from its Phase 1/2 study of PLX9486 in gastrointestinal stromal tumors

Earnings

Burning Rock Biotech Ltd (NASDAQ: BNR) (before the market open)

IPOs

San Diego, California-based Maravai Lifsciences Holding, Inc. priced its upsized initial public offering of 60 million shares at $27 each, compared to the estimated price range of $24-$27.

The shares of the company — which provides critical products to enable the development of drug therapies, diagnostics, novel vaccines and support research on human diseases — will be listed on the Nasdaq under the ticker symbol "MRVI."

Sotera Health Company, a global provider of sterilization and lab testing and advisory services to the medical device and pharmaceutical industries, priced its 46.6-million share IPO at $23, the upper end of the estimated price range of $20-$23. The shares of the Broadview Heights, Ohio-based company will be listed on the Nasdaq under the ticker symbol "SHC."

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

 

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