The Daily Biotech Pulse: Legal Relief For Evolus, Fulgent to Join S&P SmallCap 600, AIM ImmunoTech's Positive Cancer Drug Readout
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)
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Cardiff Oncology Inc (NASDAQ: CRDF)
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Castle Biosciences Inc (NASDAQ: CSTL)
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Evogene Ltd (NASDAQ: EVGN)
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Guardant Health Inc (NASDAQ: GH)
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Pacific Biosciences of California Inc (NASDAQ: PACB)
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PPD Inc (NASDAQ: PPD)
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SpringWorks Therapeutics Inc (NASDAQ: SWTX)
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TFF Pharmaceuticals Inc (NASDAQ: TFFP)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Sept. 21)
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Amarin Corporation plc (NASDAQ: AMRN)
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Athira Pharma Inc (NASDAQ: ATHA) (went public Friday)
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Checkmate Pharmaceuticals Inc (NASDAQ: CMPI)
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Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP)
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DBV Technologies ADR Representing 0.5 Ord Shs (NASDAQ: DBVT)
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Dyne Therapeutics Inc (NASDAQ: DYN) (went public Thursday)
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Genetron Holdings Ltd – ADR (NASDAQ: GTH)
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Genfit SA (NASDAQ: GNFT)
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Harmony Biosciences Holdings Inc (NASDAQ: HRMY)
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Histogen Inc (NASDAQ: HSTO)
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Intercept Pharmaceuticals Inc (NASDAQ: ICPT)
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Legend Biotech Corp (NASDAQ: LEGN)
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Metacrine Inc (NASDAQ: MTCR) (went public Wednesday)
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ORIC Pharmaceuticals Inc (NASDAQ: ORIC)
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Pandion Therapeutics Inc (NASDAQ: PAND)
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Renalytix AI PLC (NASDAQ: RNLX)
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SILENCE THERAPE/S ADR (NASDAQ: SLN)
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Taro Pharmaceutical Industries Ltd. (NYSE: TARO)
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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.
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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