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Week Ahead (Jun.7 - 11): FDA Decision, Data Readouts (LMNL, BIIB, CGEN, ELDN…)

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In the holiday-shortened trading week that ended June 4, 2021, 3 stocks registered gains of more than 50%.

Constellation Pharmaceuticals Inc. (CNST), with over 69% weekly gain, was the top performer of the week. On June 2, Constellation announced that it had signed an agreement to merge with MorphoSys (MOR) for approximately $1.7 billion.

The other two stocks among the top performers of the week were BriaCell Therapeutics Corp. (BCTX), with a gain of nearly 63%, and Windtree Therapeutics Inc. (WINT), which delivered 50% gain.

Now, let's take a look at some of the stocks that are worth watching in the upcoming week.

1. Liminal BioSciences Inc. (LMNL)

Liminal BioSciences, after the bell Friday (June 4), announced that the FDA has approved Ryplazim for the treatment of patients with plasminogen deficiency type 1.

Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood. Patients may be born with the inability to produce sufficient plasminogen naturally - a condition referred to as congenital plasminogen deficiency (C-PLGD), or suffer an acute or acquired deficiency following a trauma or an illness.

Ryplazim becomes the first FDA approved therapy for this rare genetic disorder.

Ryplazim was previously granted Orphan Drug and Rare Pediatric Disease Designations by the FDA for the treatment of congenital plasminogen deficiency.

LMNL closed Friday's (June 4, 2021) trading at $4.02, down 3.13%.

2. Biogen Inc. (BIIB)

Biogen Inc.'s (BIIB) Aducanumab, an investigational treatment for Alzheimer's disease, is under FDA review, with a decision anticipated on June 7.

Biogen licensed Aducanumab from Neurimmune AG under a collaborative development and license agreement. Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of Aducanumab globally.

No new Alzheimer's drug has been approved since 2003 - the year, in which Forest Labs' Namenda was approved in the U.S.

Last November, an FDA panel recommended against approval of Aducanumab. The U.S. regulatory agency usually follows the recommendations of its panel, although it is not required to do so.

Research firm Evaluate Vantage has estimated that Aducanumab, if approved, has the potential to achieve peak sales of $4.9 billion by 2026.

BIIB closed Friday's trading at $286.14, up 4.99%.

3. Compugen Ltd. (CGEN)

Compugen will be presenting updated data from its ongoing phase I clinical trial of COM701 for the treatment of solid tumors, at the ASCO Annual Meeting on June 7.

COM701 is being evaluated as a monotherapy and in combination with Bristol Myers Squibb's Opdivo.

CGEN closed Friday's trading at $7.23, down 1.63%.

4. Eledon Pharmaceuticals Inc. (ELDN)

Eledon Pharma is slated to present phase I data on the safety, tolerability and pharmacokinetics of AT -1501, and pre-clinical data showing the effectiveness of AT-1501 in preventing islet allograft rejection in nonhuman primate models at the American Transplant Congress on June 7.

The company is expected to initiate a phase II trial of AT-1501 in islet cell transplantation in the near term.

A phase II trial of AT-1501 in an autoimmune nephritis indication is expected to be initiated in late 2021.

ELDN closed Friday's trading at $9.10, up 0.66%.

5. Gossamer Bio Inc. (GOSS)

Gossamer is scheduled to present additional clinical data from its ongoing Phase 1/2 trial of GB1275 as a monotherapy and in combination with KEYTRUDA, in advanced solid tumors, dubbed KEYNOTE-A36, at the ASCO 2021 Annual Meeting on June 7.

The company reported positive safety and biomarker data from the KEYNOTE-A36 trial last year, which showed early signs of biologic and clinical activity of GB1275.

GOSS closed Friday's trading at $8.51, down 0.23%.

6. PDS Biotechnology Corporation (PDSB)

PDS Biotech will be presenting the previously announced interim data from its phase II trial of PDS0101 in patients with HPV16-associated cancers at the 2021 ASCO Annual Meeting on June 7.

The trial is evaluating PDS0101 in combination with two investigational immune-modulating agents, bintrafusp alfa and NHS-IL12 in both checkpoint inhibitor naïve and refractory patients with advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment.

Bintrafusp alfa is being jointly developed by Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA, Darmstadt, Germany.

According to the interim data, reported last month, the trial demonstrated an overall objective response rate of 71% (10/14) in patients with refractory HPV16-associated cancers - with 1 complete response (anal cancer) and 9 partial responses (3 cervical cancer, 2 vulvar/vaginal cancer, 2 anal cancer, 2 oropharyngeal cancer).

Ninety percent of these responses are ongoing after a median 5 months of follow up, according to the company.

PDSB closed Friday's trading at $12.78, up 13.10%.

7. Chinook Therapeutics Inc. (KDNY)

Chinook Therapeutics will be presenting interim results of phase I and phase II trials of BION-1301 in patients with IgA nephropathy at the 58TH ERA-EDTA Congress on June 8.

IgA nephropathy is a chronic autoimmune kidney disease. In patients with IgA nephropathy, plasma cells secrete abnormal, galactose-deficient IgA (Gd-IgA1). As the disease advances, patients with IgA nephropathy may require dialysis or kidney transplantation.

KDNY closed Friday's trading at $16.81, up 0.72%.

8. Precigen Inc. (PGEN)

Precigen will be presenting interim data from its phase 1b/2a clinical trial of AG019 for the treatment of early-onset Type 1 diabetes (T1D) at the Federation of Clinical Immunology Societies (FOCIS) 2021 Virtual Annual Meeting on June 10.

The phase 1b/2a clinical trial is evaluating AG019 ActoBiotics as a monotherapy and in combination with Teplizumab, a phase 3 anti-CD3 monoclonal antibody in development for the interception and prevention of clinical T1D.

Last August, the company announced that the phase Ib monotherapy portion of the ongoing phase 1b/2a clinical study of AG019 ActoBiotics met the primary endpoint of safety and tolerability.

PGEN closed Friday's trading at $6.67, up 1.52%.

9. Alexion Pharmaceuticals Inc. (ALXN)

Caelum Biosciences and Alexion Pharma will present new data from their phase II open-label dose escalation study evaluating the safety and tolerability of CAEL-101 in combination with standard-of-care (SoC) therapy in AL amyloidosis at the European Hematology Association on June 11.

A phase III clinical program evaluating CAEL-101 in combination with SoC therapy in AL amyloidosis is underway.

ALXN closed Friday's trading at $177.12, up 0.76%.

10. bluebird bio Inc (BLUE)

bluebird bio will present data from its ongoing clinical studies of betibeglogene autotemcel (beti-cel) at the 26th Annual Congress of the European Hematology Association on June 11.

The data to be presented include updated results from the Phase 3 Northstar-2 (HGB-207) and the Phase 3 Northstar-3 (HGB-212) studies, as well as long-term efficacy and safety results from the LTF-303 follow-up study.

Additionally, data from the company's Phase 1/2 HGB-206 study of LentiGlobin for sickle cell disease will be shared.

BLUE closed Friday's trading at $30.92, up 0.72%.

11. Celyad Oncology SA (CYAD)

Celyad will be presenting initial clinical data from its phase I trial of CYAD-211 for relapsed/refractory (r/r) multiple myeloma, dubbed IMMUNICY-1, at the European Hematology Association (EHA) Virtual Congress on June 11.

According to the initial data revealed last month, CYAD-211 showed preliminary signs of clinical activity, including a confirmed partial response, with no evidence of Graft-versus-Host-Disease in the IMMUNICY-1 trial.

CYAD-211 is an investigational, non-gene edited allogeneic CAR T candidate engineered to co-express a single hairpin RNA (shRNA) and a BCMA-targeting chimeric antigen receptor.

CYAD closed Friday's trading at $5.51, down 0.18%.

12. Vertex Pharmaceuticals Inc. (VRTX)

Vertex Pharma will be presenting updated data from their ongoing CTX001 clinical trials at the European Hematology Association Virtual Congress on June 11.

CTX001 is being jointly developed by CRISPR Therapeutics and Vertex Pharmaceuticals for hemoglobin-associated diseases, including Sickle Cell Disease and transfusion-dependent beta thalassemia.

A phase 1/2 study of CTX001 in subjects with transfusion-dependent ß-thalassemia and a phase 1/2 study of CTX001 in subjects with severe Sickle Cell Disease are underway.

VRTX closed Friday's trading at $209.93, down 0.58%.

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