The Daily Biotech Pulse: Patent Win For Amarin, FDA Nod For Novartis & Merck, Chembio's Coronavirus EUA Revoked

Here's a roundup of top developments in the biotech space over the last 24 hour.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 16)

  • ADC Therapeutics SA ADCT
  • Adverum Biotechnologies Inc ADVM (named a new CEO)
  • Amicus Therapeutics, Inc. FOLD
  • Applied Molecular Transport Inc AMTI (IPOed June 5)
  • Biohaven Pharmaceutical Holding Co Ltd BHVN
  • Eli Lilly And Co LLY (announced FDA approval for its rapidly-acting insulin injection, and positive results for its breast cancer study)
  • Brainstorm Cell Therapeutics Inc BCLI
  • Celldex Therapeutics, Inc. CLDX
  • Celsion Corporation CLSN
  • Cerus Corporation CERS
  • Evoke Pharma Inc EVOK
  • Fennec Pharmaceuticals Inc FENC
  • Ideaya Biosciences Inc IDYA( announced an oncology partnership with GlaxoSmithKline plc GSK)
  • Immunovant Inc IMVT
  • ITAMAR MED LTD/S ADR ITMR
  • Momenta Pharmaceuticals, Inc. MNTA
  • Nemaura Medical Inc NMRD(presented sugarBEAT continuous glucose monitor for patients with Type 2 diabetes at the virtual ADA conference)
  • Neubase Therapeutics Inc NBSE
  • Nymox Pharmaceutical Corp NYMX
  • Ocular Therapeutix Inc OCUL
  • Odonate Therapeutics Inc ODT
  • Passage Bio Inc PASG
  • Pliant Therapeutics Inc PLRX
  • Sarepta Therapeutics Inc SRPT
  • SpringWorks Therapeutics Inc SWTX
  • TELA Bio Inc TELA
  • Trillium Therapeutics Inc TRIL
  • Vaxcyte Inc PCVX(IPOed Friday)
  • Zynex Inc. ZYXI

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 16)

  • Generation Bio Co GBIO (IPOed Friday)
  • Lantern Pharma Inc LTRN (IPOed Thursday)

Related Link: Sinovac Makes Headway In Coronavirus Vaccine Race With Positive Preliminary Phase 1/2 Results

Stocks In Focus

Fulgent's At-home COVID Testing Solution Gets FDA's EUA

Fulgent Genetics Inc FLGT said it has received FDA's Emergency Use Authorization, or EUA, for its at-home testing solution for COVID-19. The company added it has launched the testing solution and that its testing service will be made available through Picture Genetics, its consumer-initiated genetic testing platform, beginning next week.

The stock soared 18.18% to $19.50 in the after-hours trading.

Amarin, Apotex Settle Patent Litigation Regarding Generic Vascepa

Amarin Corporation plc AMRN announced a settlement agreement with Apotex to resolve patent litigation regarding an ANDA filed by the latter for a generic form of the former's Vascepa.

As part of the settlement agreement, Apotex is precluded from selling a generic version in the U.S. until Aug. 9, 2029, or earlier under certain customary circumstances such as Amarin not prevailing in the pending appeal of the March 2020 Nevada district court decision.

The stock added 5.37% to $7.26 in after-hours trading.

Merck Gets Another FDA Approval For Keytruda, Prices $4.5B Debt Offering

Merck & Co., Inc. MRK announced FDA approval for its Keytruda anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test.

Separately, the company said it has priced $4.5 billion public offering of four series of senior unsecured notes.

Novartis Cosentyx Gets FDA Approval For Additional Indication

Novartis AG NVS said the FDA approved its Cosentyx for the treatment of active non-radiographic axial spondyloarthritis, confirming its efficacy in addressing the axial spondyloarthritis disease spectrum.

EUA For Chembio's Coronavirus Antibody Test Revoked

The FDA said it has revoked its EUA for Chembio Diagnostics Inc's CEMI DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, citing performance concerns with the accuracy of the test.

The stock slumped 31.02% to $6.85 in after-hours trading.

Zomedica Appoints Medical Device Industry Veteran Robert Cohen as Interim CFO

Zomedica Pharmaceuticals Corp ZOM announced the appointment of medical devices industry veteran Robert Cohen as its Interim CEO, effective immediately, even as it gears to launch its Truforma point-of-care diagnostic platform. Shameze Rampertab, who was serving as interim CEO, will continue in his role as CFO, the company added.

The stock advanced 14.21% to 22 cents in after-hours trading.

PTC Gets FDA Nod To Initiate Phase 2/3 Study For Potential COVID-19 Treatment

PTC Therapeutics, Inc. PTCT said the FDA has authorized the initiation of a Phase 2/3 trial to investigate PTC299, a dihydroorotate dehydrogenase inhibitor, as a potential treatment for COVID-19.

The company said the investigational asset has the potential to address the two critical elements of COVID-19 - high viral replication and uncontrolled inflammatory response that ensues after infection. The company also said it plans to initiate an integrated Phase 2/3 study in the U.S. in the coming days with additional sites planned globally

Inspire's Therapy To Be Covered By Cigna

Inspire Medical Systems Inc INSP said Cigna Corp CI will provide coverage for its Inspire therapy, effective June 15, 2020.

"With the addition of Cigna, we now have 54 coverage policies, representing over 180 million members, that cover Inspire therapy, compared to 83 million members just one year ago," Inspire said.

Progenics Shareholders Approve Merger With Lantheus

Progenics Pharmaceuticals, Inc. PGNX said its shareholders approved its previously-announced merger with Lantheus Holdings Inc LNTH. The merger is now subject to customary closing conditions and is expected to close on or about June 19.

Ipsen Gets Fast Track Designation For Pancreatic Cancer Drug

IPSEN S A/S ADR IPSEY said the FDA granted the Fast Track designation for the investigational use of liposomal irinotecan in combination with 5- fluorouracil/leucovorin and oxaliplatin, for patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma.

Offerings

Provention Bio Inc PRVB said it has commenced an underwritten public offering of 5.5 million shares of its common stock. All of the shares to be sold in the offering are to be sold by the company.

The stock slipped 5.54% to $15.52 in after-hours trading.

AVEO Pharmaceuticals, Inc. AVEO said it has priced its previously announced underwritten public offering of 8.5 million shares of its common stock at $5.25 per share, for raising gross proceeds of $44.6 million. The offering is expected to close on or about June 19.

The stock fell 4% to $6 in after-hours trading.

Actinium Pharmaceuticals Inc ATNM priced its secondary offering of 76.923 million shares at 32.5 cents per share for raising gross proceeds of $25 million. The offering is expected to close on or about June 19.

The stock plunged 17.98% to 36 cents after-hours trading.

Shockwave Medical Inc SWAV priced its public offering of 1.7 million shares at $45.75 per share, The offering is expected to raise gross proceeds of $77.8 million and close on or about June 19.

On The Radar

Adcom Meetings

FDA's Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will consider through teleconferencing SP 2577 presentation by Salarius Pharmaceuticals Inc SLRX and marizomib, presentation by Celgene, a subsidiary of Bristol-Myers Squibb Co BMY. SP 2577 is being evaluated for the treatment of relapsed/refractory patients with Ewing sarcoma and marizomib for multiple myeloma.

The FDA said the subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate.

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