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The Daily Biotech Pulse: Legal Relief For Evolus, Fulgent to Join S&P SmallCap 600, AIM ImmunoTech's Positive Cancer Drug Readout

Shanthi Rexaline
·5 mins read

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 Sept. 21)

  • Cardiff Oncology Inc (NASDAQ: CRDF)

  • Castle Biosciences Inc (NASDAQ: CSTL)

  • Evogene Ltd (NASDAQ: EVGN)

  • Guardant Health Inc (NASDAQ: GH)

  • Pacific Biosciences of California Inc (NASDAQ: PACB)

  • PPD Inc (NASDAQ: PPD)

  • SpringWorks Therapeutics Inc (NASDAQ: SWTX)

  • TFF Pharmaceuticals Inc (NASDAQ: TFFP)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 21)

  • Amarin Corporation plc (NASDAQ: AMRN)

  • Athira Pharma Inc (NASDAQ: ATHA) (went public Friday)

  • Checkmate Pharmaceuticals Inc (NASDAQ: CMPI)

  • Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP)

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

  • Dyne Therapeutics Inc (NASDAQ: DYN) (went public Thursday)

  • Genetron Holdings Ltd – ADR (NASDAQ: GTH)

  • Genfit SA (NASDAQ: GNFT)

  • Harmony Biosciences Holdings Inc (NASDAQ: HRMY)

  • Histogen Inc (NASDAQ: HSTO)

  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT)

  • Legend Biotech Corp (NASDAQ: LEGN)

  • Metacrine Inc (NASDAQ: MTCR) (went public Wednesday)

  • ORIC Pharmaceuticals Inc (NASDAQ: ORIC)

  • Pandion Therapeutics Inc (NASDAQ: PAND)

  • Renalytix AI PLC (NASDAQ: RNLX)

  • SILENCE THERAPE/S ADR (NASDAQ: SLN)

  • Taro Pharmaceutical Industries Ltd. (NYSE: TARO)

  • Viveve Medical Inc (NASDAQ: VIVE)

Stocks In Focus Trade Commission Agrees to Review Ruling On Jeuveau, Evolus' Botox Competitor 

Evolus Inc (NASDAQ: EOLS) shares reacted to an announcement by the U.S. International Trade Commission that it will review a judge's findings that Jeuveau is made with a secret process stolen from the Korean partner of AbbVie Inc's (NYSE: ABBV) Allergan unit, Medytox Inc. A final decision in the case is expected in November.

In an initial determination, a trade judge ruled that Evolus violated section 337 of the Tariff Act of 1930, as amended, and recommended a 10-year ban on Jeuveau imports.

Evolus rallied 14.25% to $4.01 in after-hours trading.

AstraZeneca Strikes Biologics Supply Agreement With Samsung Biologics

AstraZeneca plc (NYSE: AZN) and Samsung Biologics announced a long-term supply agreement valued at about $330.8 million that calls for Samsung Biologics to provide large-scale commercial manufacturing for drug substance in its Plant 3 as well as drug product to support AstraZeneca's biologics therapeutics.

The value of the contract could be increased to $545.6 million, the companies said.

AstraZeneca shares were down 1.45% to $55.10 in premarket trading Tuesday.

Bristol-Myers Squibb, bluebird Bio Announce BLA Acceptance For Multiple Myeloma CAR T-Cell Therapy 

Bristol-Myers Squibb Co (NYSE: BMY) and bluebird bio Inc (NASDAQ: BLUE) said the FDA has accepted for priority review their biologics license application for idecabtagene vicleucel, their investigational B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy.

The therapy is intended for adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

See also: The Week Ahead In Biotech: Conference Presentations, IPOs In The Mix

AIM ImmunoTech Announces Positive Survival Results From Pancreatic Cancer Study

AIM ImmunoTech Inc (NYSE: AIM) announced receipt of statistically significant positive pancreatic cancer survival results from a multiyear Early Access Program conducted at Erasmus University Medical Center in the Netherlands.

The study provided Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy.

In premarket trading Tuesday, AIM Immunotech shares were rallying 29.41% to $2.64.

Bausch Health Agrees To Resolve Patent Lawsuit Over Traveler's Diarrhea Drug

Bausch Health Companies Inc (NYSE: BHC) and its Salix Pharma unit — along with Salix's licensor Alfasigma — said they have agreed to resolve the outstanding intellectual property disputes with Sun Pharmaceutical Industries Ltd. regarding Xifaxan 200mg and 550mg tablets.

View more earnings on EOLS

The Salix parties will grant Sun a non-exclusive license effective Jan. 1, 2028 to its intellectual property relating to these tablets in the U.S.

In premarket trading, Bausch shares were adding 0.48% to $16.60.

Fulgent Genetics To Join S&P SmallCap 600 Index

Fulgent Genetics Inc (NASDAQ: FLGT), which has found some momentum courtesy of its COVID-19 test, said it will replace Garrett Motion Inc (NYSE: GTX) in the S&P SmallCap 600 before the opening of trading on Friday, Sept. 25.

Fulgent shares were trading 9.66% higher at $41.22 premarket Tuesday. 

ADC Makes Regulatory Submission For Blood Cancer Drug

ADC Therapeutics SA (NYSE: ADCT) said it has submitted a biologics license application to the FDA for loncastuximab tesirine, or Lonca, for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.

"The completion of our first BLA submission to the FDA is a significant milestone for ADC Therapeutics and takes us one step further in our evolution toward becoming a commercial-stage organization," said Chris Martin, CEO of ADC.

Separately, the company announced the commencement of a proposed underwritten public offering of 5.5 million of its common shares.

Earnings

Erytech Pharma SA (NASDAQ: ERYP) announced a wider loss for the first half of 2020.

Separately, the company announced an at-the-market program allowing it to issue and sell ordinary shares in the form of ADSs to eligible investors at market prices, with aggregate gross sales proceeds of up to $30 million, subject to a regulatory limit of 20% dilution, from time to time.

Offerings

Aileron Therapeutics Inc (NASDAQ: ALRN) said it has entered into a common stock purchase agreement for up to $15 million with Lincoln Park Capital Fund, a Chicago-based institutional investor and Aileron shareholder.

Protara Therapeutics Inc (NASDAQ: TARA) announced its intention to offer shares of its common stock and Series 1 convertible preferred stock in two concurrent but separate underwritten public offerings.

The stock shed 0.41% to $16.80 in after-hours trading.

On The Radar Clinical Readouts

vTv Therapeutics Inc (NASDAQ: VTVT) will present at the 56th annual meeting of the European Association for the Study of Diabetes additional positive clinical study results from the Phase 2 Simplici-T1 study of TTP399 as adjunctive therapy for patients with Type 1 diabetes.

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

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