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The Daily Biotech Pulse: Osmotica Faces Second FDA Rejection, UK Conditionally Approves AstraZeneca's Vaccine Candidate, Hepion NASH Data

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·6 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 Dec. 29)

  • ABIOMED, Inc. (NASDAQ: ABMD)

  • Apellis Pharmaceuticals Inc (NASDAQ: APLS)

  • Atea Pharmaceuticals, Inc. (NASDAQ: AVIR)

  • Bioanalytical Systems, Inc. (NASDAQ: BASI)

  • BioNano Genomics Inc (NASDAQ: BNGO)

  • Clearpoint Neuro Inc (NASDAQ: CLPT)

  • DermTech Inc (NASDAQ: DMTK)

  • Edwards Lifesciences Corp (NYSE: EW)

  • Inari Medical Inc (NASDAQ: NARI)

  • Lumos Pharma Inc (NASDAQ: LUMO)

  • Mersana Therapeutics Inc (NASDAQ: MRSN)

  • Organogenesis Holdings Inc (NASDAQ: ORGO)

  • Praxis Precision Medicines Inc (NASDAQ: PRAX)

  • Silverback Therapeutics Inc (NASDAQ: SBTX) (sell-side initiated coverage of shares following IPO quiet period expiry)

  • Spero Therapeutics Inc (NASDAQ: SPRO)

  • Tenax Therapeutics Inc (NASDAQ: TENX) (moved on analyst action)

  • TRACON Pharmaceuticals Inc (NASDAQ: TCON)

  • Titan Medical Inc. (NASDAQ: TMDI)

  • United Therapeutics Corporation (NASDAQ: UTHR)

  • X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Dec. 29)

  • AbCellera Biologics Inc (NASDAQ: ABCL)

  • Aprea Therapeutics Inc (NASDAQ: APRE)

  • Cortexyme Inc (NASDAQ: CRTX)

  • Hoth Therapeutics Inc (NASDAQ: HOTH)

  • Immunome Inc (NASDAQ: IMNM)

  • Inhibikase Therapeutics Inc (NASDAQ: IKT) (went public Wednesday)

  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT)

  • Lixte Biotechnology Holdings Inc (NASDAQ: LIXT)

  • Pharming Group N.V. (NASDAQ: PHAR) (went public Wednesday)

  • Qualigen Therapeutics Inc (NASDAQ: QLGN)

  • Virios Therapeutics LLC (NASDAQ: VIRI)

  • Vivos Therapeutics Inc (NASDAQ: VVOS)

Stocks In Focus Immutep Awarded Patent Related To Lead Compound Eftilagimod Alpha

Immutep ADS Representing 10 Ord Shs (NASDAQ: IMMP) announced the award of a patent entitled "Combined Preparations for the Treatment of Cancer or Infection" by the U.S. Patent & Trade Mark Office.
The claims of the patent protect Immutep's intellectual property relating to combined preparations comprising its lead active immunotherapy candidate eftilagimod alpha and a PD-1 pathway inhibitor, which is either Keytruda or Opdivo.

The expiry date of the patent is Jan. 8, 2036.

The stock was up 18.98% premarket at $3.38.

Osmotica Handed Complete Response Letter For Multiple Sclerosis Spasticity Drug

Osmotica Pharmaceuticals PLC (NASDAQ: OSMT) said the FDA issued a complete response letter for its NDA seeking approval for the investigational agent arbaclofen extended release tablets to treat spasticity resulting from multiple sclerosis.

The FDA made a number of recommendations, including that the company conduct a new study in order to provide substantial evidence of efficacy of arbaclofen, Osmotica said.

This is the second rejection the company is facing for arbaclofen.

The stock was down 27.22% premarket Wednesday at $3.85. 

AstraZeneca's Coronavirus Vaccine Gets Conditional Approval In UK

AstraZeneca plc (NASDAQ: AZN) received conditional approval for AZD1222, the coronavirus vaccine candidate it is jointly developing with the Oxford University, for the active immunization of individuals 18 years or older.

The stock was gaining 1.92% to $50.86 premarket Wednesday.

Regeneron Antibody Cocktail Passes Futility Analysis In Hospitalized COVID-19 Patient Study; Phase 3 Trial To Continue

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) announced positive initial data from the Phase 1/2/3 clinical study of its investigational antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen.

The results passed the futility analysis, as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation. The results began to show one week following the treatment, with the risk of death or receiving mechanical ventilation reduced by approximately half, based on a post-hoc analysis.

The antibody combination is also being evaluated in outpatient setting.

The stock was up 0.37% to $486 in after-hours trading.

Related Link: The Week Ahead In Biotech (Dec. 27-Jan. 2): Data Releases, Regulatory Filings To Move Stocks

Hepion Reports Positive Midstage Results For Low-Dose Cohort In NASH Study

Hepion Pharmaceuticals Inc (NASDAQ: HEPA) announced topline data from the low-dose cohort in the Phase 2a AMBITION clinical trial of CRV431 in NASH patients with evidence of moderate-to-severe fibrosis, showing CRV431 was generally safe and well-tolerated.

Biomarkers of efficacy, including declines in alanine aminotransferase and aspartate aminotransferase from baseline to day 28 were observed, with mean declines of 18.4% and 12.1%, respectively. This compares to a 0.65% decline and a 2.52% increase in alanine aminotransferase and aspartate aminotransferase, respectively, in the placebo group, Hepion said.

This Phase 2a study is continuing with the higher dose of 225 mg CRV431, with NASH patient dosing expected to be completed in the first quarter of 2021.

Hepion said it expects to release final results from both dosing cohorts after the high dose group has completed active dosing, followed by a 14-day observation period.

The stock jumped 37.02% to $2.85 premarket Wednesday. 

Moderna In Talks to Supply Over 40M Doses Of Coronavirus Vaccine To South Korea

Moderna Inc (NASDAQ: MRNA) said it is engaged in discussions with the South Korean government to potentially provide 40 million or more doses of its COVID-19 vaccine. Distribution of the vaccine would begin in the second quarter of 2021.

Moderna shares were trading 2.89% higher premarket at $117.70.

Emergent Biosolutions Starts Phase 1 Study Of Plasma Therapy For Prophylactic Treatment Of COVID-19 Post Exposure

Emergent Biosolutions Inc (NYSE: EBS) and Mount Sinai Health System announced initiation of the clinical program to evaluate Emergent's COVID-19 human hyperimmune globulin product candidate in the first of two Phase 1 studies to support its use for potential post-exposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2, such as front-line health care workers and military personnel.

The Department of Defense has provided $34.6 million in funding in support of this program.

The stock added 2.06% to $92 premarket Wednesday.

PDL BioPharma Rises On Fund Buying

PDL BioPharma Inc (NASDAQ: PDLI) shares rose after hedge fund Silver Point Capital, a major shareholder, purchased 631,600 shares at prices ranging between $2.65 and $2.70.

The stock was up 1.48% to $2.74 premarket.

ClearPoint Neuro Announces Incremental $7.5M Debt Funding, Easing Of Debt Covenants

ClearPoint Neuro announced an amendment to its January 2020 secured convertible note financing agreement with Petrichor Healthcare Capital Management and PTC Therapeutics, Inc (NASDAQ: PTCT) with the amendment providing for an additional $7.5-million strategic investment from Petrichor.

The amendment also improves terms relative to the original conversion price and interest rate, ClearPoint said.

The stock rose 12.62% to $16.15 in after-hours trading.

DermTech Gets Positive Medical Coverage For Gene Expression Test To Detect Melanoma

DermTech said Geisinger Health System has issued a positive medical benefit policy for the DermTech Pigmented Lesion Assay, or PLA. PLA is the first non-invasive gene expression test for the early detection of melanoma, and it has a 99% negative predictive value.
DermTech shares were up 7.1% premarket at $30. 

Related Link: 5 Biotech Stocks That Generated 1,000%+ Returns In 2020

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