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The Daily Biotech Pulse: Applied DNA Ships Vaccine Constructs For Animal Testing, Herceptin Biosimilar Now Available In US

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·5 min read
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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 April 14)

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

  • Acceleron Pharma Inc (NASDAQ: XLRN)

  • Dr.Reddy's Laboratories Ltd (NYSE: RDY)

  • Kala Pharmaceuticals Inc (NASDAQ: KALA)

  • Keros Therapeutics Inc (NASDAQ: KROS) (IPOed April 8)

  • Masimo Corporation (NASDAQ: MASI)

  • MEI Pharma Inc (NASDAQ: MEIP)(announced a licensing agreement with Japan's Kyowa Kirin for developing its ME-401, which is being evaluated for B-cell malignancies)

  • Neoleukin Therapeutics Inc (NASDAQ: NLTX)

  • Neubase Therapeutics Inc (NASDAQ: NBSE)

  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN)

  • SUMMIT THERAPEU/S ADR (NASDAQ: SMMT)(announced appointment of controlling shareholder Robert Duggan as CEO)

Down In The Dumps

(Biotech Stocks Hitting 52-Week Lows April 14)

  • Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)(announced a 1-for-20 reverse stock split, effective close of trading Tuesday)

  • TherapeuticsMD Inc (NASDAQ: TXMD)

See Also: Gilead Analysts Break Down Remdesivir Data Readout From Compassionate Use

Stocks In Focus Pfenex Says FDA Requests Additional Data For Establishing Bioequivalence Of Osteoporosis Drug To Forteo

Pfenex Inc (NYSE: PFNX) said the FDA informed its commercialization partner Alvogen Malta Operations through a General Advice letter, additional comparative use human factors data, especially from Forteo experienced users, would be required before PF708 Therapeutic Equivalence could be determined.

Forteo is Eli Lilly And Co's(NYSE: LLY) drug indicated to treat ostmenopausal women with osteoporosis at high risk for fracture.

"We intend to work closely with Alvogen and the FDA to expeditiously move toward a solution addressing the Agency's expressed views, so that we can submit additional data as soon as possible," said Eef Schimmelpennink, CEO of Pfenex.

The company also said it will continue to support Alvogen with its commercial strategy planning in the U.S. while continuing to seek "A" therapeutic equivalence designation.

Crinetics Announces 7.15M Common Stock Offering

Crinetics Pharmaceuticals Inc (NASDAQ: CRNX) priced its underwritten public offering of 7.15 million shares at $14 per share. All the shares are being offered by the company. The company expects to raise gross proceeds of $100.1 million from the offering. The offering is expected to close on or about April 17.

The company said it intends to use the net proceeds to fund the development of paltusotine and other R&D programs, and for working capital and general corporate purposes.

Athersys Given Go Ahead To Initiate Midstage Study Of Stem Cell Therapy For Traumatic Injuries

Athersys Inc (NASDAQ: ATHX) said the FDA has authorized an IND to initiate a Phase 2 study evaluating its MultiStem cell therapy for early treatment of traumatic injuries and the subsequent complications that result following severe trauma.

Applied DNA Ships 5 Vaccine Constructs To Begin Animal Testing In Italy

Applied DNA Sciences Inc (NASDAQ: APDN) said it has completed design, qualification, production and shipment of five COVID-19 vaccine candidates to Italy-based Takis Biotech to start preclinical testing immediately. The vaccine candidates, according to the company, were produced by its proprietary PCR-based Linear DNA manufacturing systems.

"Preliminary animal test results from the plasmid-based vaccine templates, from which Applied DNA's linear DNA-based vaccine constructs were manufactured at scale, were immunogenic and induced a strong production of antibodies across all five vaccine candidates," said Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech.

In pre-market trading, shares were surging up 43.96% to $6.55.

Merck Announces U.S. Launch Of Biosimilar For Roche's Popular Breast Cancer Drug

Merck & Co., Inc. (NYSE: MRK) announced the U.S. launch of Ontruzant, a biosimilar of the reference biologic medicine Herceptin - Roche Holdings AG's (OTC: RHHBY) breast cancer drug.

The company noted that the biosimilar will be available in both 150 mg single-dose vials, priced at WAC of $1,325, and 420mg multiple-dose vials, priced at $3,709. This represented a 15% discount to the current list price of Herceptin.

Ontruzant is developed by Samsung Bioepis, with Merck assuming the responsibility of the commercialization of the biosimilar in the U.S.

In pre-market trading, Merck shares were slipping 1.44% to $81.65.

Mallinckrodt Announces Publication Of Positive Efficacy Data For Acthar Gel

Mallinckrodt PLC (NYSE: MNK) announced the publication of findings from a Phase 4 study to assess the safety and efficacy of Acthar Gel in patients with persistently active rheumatoid arthritis, with Acthar Gel demonstrating the potential for effectiveness in achieving low disease activity as assessed by DAS28-ESR2 in patients with active RA despite current treatment with low-dose glucocorticoids and one or two DMARDs.

The stock was gaining 1.53% to $3.99 in pre-market trading.

Oragenics' Antibiotic Candidate Flunks Midstage Study In Treating Oral Mucositis

Oragenics Inc (NYSE: OGEN) said early top-line results of the company's Phase 2 clinical trial of AG013 in oral mucositis in chemoradiation in head and neck cancer patients did not demonstrate statistical significance on the primary endpoint of severe oral mucositis duration when compared to placebo.

The stock slumped 46.20% to 43 cents in premarket trading Wednesday.

On The Radar Clinical Readouts

Vir Biotechnology Inc (NASDAQ: VIR) will present at a Key Opinion leader call an update on its Phase 1/2 hepatitis B virus clinical trial with small interfering ribonucleic acid VIR-2218, Vir had licensed the investigational asset from Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY).

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