Week Ahead In Pharma: FDA Decisions, SITC Presentations, 13D SEC Filing

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During the week ended November 6, two healthcare stocks generated triple-digit gains - Aptevo Therapeutics Inc. (APVO) was up over 266% and Oncternal Therapeutics Inc. (ONCT) returned more than 152%.

Shares of Aptevo have been in a rally mode ever since the company provided an update on its ongoing phase 1/1b trial of APVO436 in patients with acute myeloid leukemia and myelodysplastic syndrome on November 3. The stock was up over 150% in extended trading Friday after a 13D SEC filing revealed that Tang Capital Partners has increased its stake to 54.4%. (13D filing is made by activist investors).

Oncternal Therapeutics was one of the trending stocks last week, following updated results from a phase I/II study of Cirmtuzumab, an anti-ROR1 antibody, in mantle cell lymphoma or chronic lymphocytic leukemia and Merck's acquisition of privately held VelosBio, whose lead candidate is also an anti-ROR1 antibody, for $2.75 billion.

Let's take a look at some of the stocks that merit attention in the week ahead.

FDA Decisions

Biogen Inc. (BIIB)

After the release of internal FDA staff documents on November 4, many were hoping that Biogen's Alzheimer's drug candidate Aducanumab would get the backing of the FDA panel on November 6.

However, much to the dismay of many, the FDA panel on Friday voted 8 to 1 that the company's late-stage studies did not provide strong evidence to support the effectiveness of Aducanumab for the treatment of Alzheimer's disease.

The FDA's final decision on Aducanumab is expected on March 7, 2021. The regulatory agency usually follows the recommendations of its panels although it is not mandatory to do so.

In the case of regulatory decisions related to new drugs, it's never over till it's over.

If approved, Aducanumab will be the first new drug in over 15 years. Will the drug candidate pass muster with the FDA or will it be sent back to the drawing board?

We'll have to wait and see.

Trading in Biogen stock was halted on Friday. The stock closed Thursday's trading at $328.90.

Supernus Pharmaceuticals Inc. (SUPN)

The FDA decision on Supernus' drug candidate SPN-812, proposed for the treatment of children and adolescents with attention deficit hyperactivity disorder, due on November 8, is yet to be announced.

SPN-812 is a novel non-stimulant and its active ingredient is Viloxazine hydrochloride which was previously marketed in Europe for many years as an antidepressant.

If approved, SPN-812 will compete with Eli Lilly's (LLY) Strattera, the first non-stimulant treatment for ADHD. Strattera, which was approved in 2002, went generic in May 2017, when several generic versions of the drug secured the FDA nod simultaneously.

While stimulant drugs are the most commonly prescribed medications for the treatment of ADHD and are considered first-line treatments, non-stimulant drugs are usually considered second-line or third-line treatments and they provide a useful alternative for children who do not tolerate stimulants well.

SUPN has traded in a range of $13.12 to $25.82 in the last 1 year. The stock closed Friday's trading at $23.58, up 2.39%.

Sanofi (SNY)

The FDA decision on Sanofi's investigational drug Sutimlimab, proposed for the treatment of hemolysis in adult patients with cold agglutinin disease, is expected on November 13.

Cold Agglutinin Disease, or CAD in short, is a chronic autoimmune hemolytic anemia that causes the body's immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). CAD patients may experience chronic anemia, profound fatigue, acute hemolytic crisis, and other potential complications, including an increased risk of thromboembolic events and early death.

It is estimated that about 5,000 people in the U.S. have CAD.

If approved, Sutimlimab would be the first and only approved treatment for hemolysis in adult patients with Cold Agglutinin Disease, with peak sales estimated at $200 million.

SNY has traded in a range of $37.62 to $55.00 in the last 1 year. The stock closed Friday's trading at $49.25, down 2.15%.

Adamis Pharmaceuticals Corp. (ADMP)

Adamis Pharma's ZIMHI Injection, proposed for the reversal of opioid overdose, awaits the FDA decision on November 15.

ZIMHI is a high dose Naloxone injection product candidate administered using a patented Symject device. Naloxone has been used as the standard treatment for opioid overdose for more than 45 years, and the currently approved dose is only 2 mg. ZIMHI is a 5 mg dose of Naloxone.

This is ZIMHI's second go-around with the FDA. Last November, the U.S. regulatory agency had declined to approve ZIMHI, raising questions related to Chemistry, Manufacturing and Controls (CMS). Addressing the CMC issues, Adamis resubmitted the ZIMHI New Drug Application to FDA in May of this year and is awaiting the decision.
According to IQVIA (IMS) National Sales Perspective, the addressable market opportunity for ZIMHI is estimated to be $330 million.

ADMP has traded in a range of $0.27 to $1.51 in the last 1 year. The stock closed Friday's trading at $0.72, up 3.57%.

Alkermes plc (ALKS)

The FDA decision on Alkermes' investigational treatment of bipolar I disorder ALKS 3831 is expected on November 15.

ALKS 3831 was backed by an FDA panel for the proposed indication last month. The regulatory agency usually follows the recommendations of its panels although it is not required to do so.

If approved, analysts expect ALKS 3831 to achieve peak sales of *$364 million in 2026. (Source: GlobalData).

ALKS has traded in a range of $11.98 to $21.88 in the last 1 year. The stock closed Friday's trading at $17.00, down 0.76%.

Presentations at the Society for Immunotherapy Cancer's (SITC) Annual Meeting

The Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting is to be held virtually from November 9-14, 2020. The objective of this annual meeting is to bring together researchers, regulatory agencies and allied health professionals involved in cancer immunology and immunotherapy and facilitate the exchange of scientific information.

The following are some of the stocks that are making presentations at the SITC Annual Meeting.

Amgen Inc. (AMGN) will be presenting initial data from phase I dose escalation study of AMG 757 for relapsed or refractory small cell lung cancer at the SITC Annual Meeting.

Arcus Biosciences Inc. (RCUS) is scheduled to present preliminary biomarker data from a phase I/Ib study of Etrumadenant + mFOLFOX in patients with gastroesophageal cancer or colorectal cancer at the SITC Annual Meeting.

Celldex Therapeutics Inc. (CLDX) will present updated interim data from the ongoing phase I dose escalation study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas, both as monotherapy and in combination with CDX-301 at the SITC meeting.

Corvus Pharmaceuticals Inc. (CRVS) is expected to present updated data from its phase I study of CPI-006 for patients with COVID-19 on November 9. Results announced from the trial in September demonstrated that all evaluable patients treated in the first two cohorts (0.3 and 1.0 mg dose of CPI-006) of the study produced significant titers of antibody to SARS-CoV-2 within seven days of receiving the treatment, with levels of antibody, including neutralizing antibodies, continually increasing out to 28 days.

Cue Biopharma Inc. (CUE) will be presenting preclinical data highlighting the IL-2 based CUE-100 series Immuno-STATs, as well as results from its ongoing dose=escalation phase I monotherapy trial with CUE-101 in patients with HPV16+ head and neck cancer on November 11 and November 12, respectively at the SITC Annual Meeting.

Genocea Biosciences Inc. (GNCA)is slated to present additional details on the clinical and immune response data from a phase 1/2a trial of GEN-009, a neoantigen vaccine, in combination with PD-1 checkpoint inhibitors in advanced solid tumors on November 9.

Gossamer Bio Inc. (GOSS) will be presenting clinical and biomarker data from the ongoing phase 1/2 clinical trial of GB1275, dubbed KEYNOTE-A36, in advanced solid tumors on November 9. On May 29th of this year, the company had presented positive safety and biomarker data from the ongoing KEYNOTE-A36 trial.

I-Mab (IMAB) is slated to present data from the U.S. phase I dose escalation trial evaluating Lemzoparlimab in relapsed or refractory malignancy at the SITC. Preliminary clinical trial results from the trial reported in August of this year demonstrated a differentiated drug profile in safety and pharmacokinetics in cancer patients.

Iovance Biotherapeutics Inc. (IOVA) will present updated data from an ongoing phase II study of LN-145 in head and neck squamous cell carcinoma on November 11 at the SITC. Four patients had a confirmed, objective response with an ORR of 44% and the disease control rate at data cutoff was 89% in 9 patients, and 7 of the 8 evaluable patients (87.5%) had a reduction in target lesions, according to the results reported by company last month.

MacroGenics Inc. (MGNX) will present updated data from its ongoing phase I dose expansion study of Tebotelimab in combination with Margetuximab in a cohort of patients with advanced HER2-positive tumors at the SITC Annual Meeting.

Nektar Therapeutics (NKTR) is slated to present phase I study of NKTR-255 in patients with relapsed/refractory hematologic malignancies on November 9.

OncoSec Medical Inc. (ONCS) will be presenting new positive interim data from its phase IIb clinical trial evaluating investigational gene therapy TAVO in combination with KEYTRUDA in patients with anti-PD-1 checkpoint refractory metastatic melanoma at the SITC Annual Meeting.

Replimune Group Inc (REPL) will be presenting updated data from a phase I/II study of RP1 combined with Opdivo in melanoma and non-melanoma skin cancer at the SITC Annual Meeting.

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