The Daily Biotech Pulse: Apellis Sinks On Data, Endo Shines On Opioid Litigation Settlement, T2 Biosystems Soars On Mutant Detection Ability of COVID Test

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. 9)

• Adagio Therapeutics, Inc. ADGI
• Axonics, Inc. AXNX
• Bio-Rad Laboratories, Inc. BIO
• Bicycle Therapeutics plc BCYC
• C4 Therapeutics, Inc. CCCC
• Catalent, Inc. CTLT
• Celldex Therapeutics, Inc. CLDX
• DexCom, Inc. DXCM
• IDEAYA Biosciences, Inc. IDYA
• Medtronic plc MDT
• MiMedx Group, Inc. MDXG
• PDS Biotechnology Corporation PDSB
• Pieris Pharmaceuticals, Inc. PIRS
• Quest Diagnostics Incorporated DGX (raised its full-year guidance)
• ResMed Inc. RMD
• Stryker Corporation SYK
• Tango Therapeutics, Inc. TNGX
• Thermo Fisher Scientific Inc. TMO
• Vera Therapeutics, Inc. VERA
• West Pharmaceutical Services, Inc. WST
• Zentalis Pharmaceuticals, Inc. ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 9)

• Absci Corporation ABSI
• BioVie Inc. BIVI
• Esperion Therapeutics, Inc. ESPR
• Forte Biosciences, Inc. FBRX
• Humanigen, Inc. HGEN (reacted to FDA rejection of issuing emergency use authorization for its COVID treatment)
• Molecular Templates, Inc. MTEM
• Seres Therapeutics, Inc. MCRB
• T2 Biosystems, Inc. TTOO
• TScan Therapeutics, Inc. TCRX
• Universe Pharmaceuticals INC UPC

Click here to access Benzinga's FDA Calendar

Stocks In Focus

Apellis Plunges On Mixed Data For Late-stage Retinal Disorder Study, IVERIC bio Moves In Sympathy

Apellis Pharmaceuticals, Inc. APLS reported mixed top-line results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan in 1,258 adults with geographic atrophy secondary to age-related macular degeneration.

The OAKS study met the primary endpoint for both monthly and every-other-month treatment with pegcetacoplan, demonstrating a significant reduction in GA lesion growth of 22% and 16%, respectively, compared to pooled sham at 12 months. However the DERBY study did not meet the primary endpoint of GA lesion growth, showing a reduction of 12% and 11%, with monthly and every-other-month treatment, respectively, compared to pooled sham at 12 months.

In a prespecified analysis of the combined studies, pegcetacoplan decreased GA lesion growth in patients with extrafoveal lesions at baseline by 26% and 23% with monthly and every-other-month treatment, respectively.

Based on results from the studies, the company said it plans to submit a new drug application for pegcetacoplan for GA to the Food and Drug Administration in the first half of 2022.

Apellis shares were plunging 31.68% to $37.99 in premarket trading, while IVERIC bio, Inc. ISEE, which has a competing late-stage therapy, was jumping 46.61% to $12.74.

Endo Gains On Settlement Of Opioid Litigation In New York, to Explore Strategic Alternatives

Endo International plc ENDP said it has settled three consolidated opioid cases pending in Suffolk County Supreme Court in the State of New York.

As a result of the settlement, Endo has been severed from the trial. The settlement fully and finally resolves all of the asserted claims in exchange for a total payment of $50 million.

Endo said it is focused on its primary goal of achieving a global settlement. The company is also currently exploring other strategic alternatives and may seek to implement one or more of those alternatives in the event it is unable to achieve a global settlement.

The stock was advancing 15.24% to $2.42 in premarket trading.

T2 Biosystems' COVID-19 Molecular Diagnostic Test Capable of Detecting Recent Mutant Strains Found In U.S.

T2 Biosystems announced that its T2SARS-CoV-2 Panel—a molecular diagnostic test that detects SARS-CoV-2 —is capable of detecting the Mu (B.1.621) and Iota (B.1.526) variants of the SARS-CoV-2 virus, which were recently confirmed to be present in the U.S.

"We are proud to announce our technology is capable of detecting additional COVID-19 variants including Mu and Iota, enabling healthcare providers with the confidence to make more informed decisions about their patients' health," said T2 Biosystems' Chairman and CEO, John Sperzel.

The stock was jumping 25.78% to $1.09 in premarket trading.

CytoDyn Announces Commencement of Phase 3 COVID-19 Trial In Brazil

CytoDyn Inc. CYDY announced the treatment of the first patient in its pivotal Phase 3 COVID-19 trial in Brazil for patients with severe symptoms. An interim analysis will be conducted 28 days following the enrollment of 245 patients, which is 40% of the total number of patients to be enrolled in the trial, the company said.

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

Corcept To Present Positive Mid-stage Results For Combo Therapy In Ovarian Cancer Study

Corcept Therapeutics Incorporated CORT said positive results from its 178-patient, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer will be featured in a proffered paper oral presentation at the European Society for Medical Oncology Congress 2021, scheduled to be held Sept. 16 – 21.

"We are extremely excited by the potential of relacorilant to treat women with recurrent platinum-resistant ovarian cancer," said Joseph Belanoff, Corcept's CEO.

The company said it plans to initiate a pivotal Phase 3 trial to confirm the positive results in the first quarter of 2022.

Offerings

Ortho Clinical Diagnostics Holdings plc OCDX priced its previously announced underwritten secondary offering of 22 million of its ordinary shares held by a selling shareholder affiliated with the Carlyle Group at a price of $17.50 per ordinary share.
The offering is expected to close on Sept.14, subject to customary closing conditions.

The stock was up 1.96% at $18.71 in after-hours trading,

On The Radar

Clinical Readouts

ImmunityBio, Inc. IBRX will present at the American Urological Association conference Phase 2/3 clinical results of IL-15 Superagonist N-803 with BCG in BCG-unresponsive bladder cancer.

Mersana Therapeutics, Inc. MRSN will host a webcast to discuss progress of its clinical development strategy for upifitamab rilsodotin and report updated interim data from the ovarian cancer expansion cohort of the UpRi Phase 1 study. The webcast is scheduled 8 am.

Earnings

BeyondSpring Inc. BYSI