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Week Ahead In Pharma: FDA Decisions, Data Readouts, ESMO Presentations

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The week that passed by saw shares of Nano-X Imaging Ltd. (NNOX) make the biggest weekly advance, gaining over 66%. The Israeli "digital X-ray device" maker made its debut on the Nasdaq as recently as August 21. Intra-Cellular Therapies Inc. (ITCI) was another healthcare stock that ended with a weekly gain of over 50%, thanks to positive topline results from a phase III study of Lumateperone in patients with bipolar depression.

Now, let's take a look at some of the stocks that merit attention in the coming week.

1. Autolus Therapeutics plc (AUTL)

Autolus is a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of hematological malignancies and solid tumors.

The company's clinical drug candidates include AUTO1, under a pivotal phase Ib/II trial in acute lymphocytic leukemia, and AUTO3, under a phase I/II trial in relapsed/refractory diffuse Large B Cell Lymphoma, dubbed ALEXANDER.

Event:

The updated data from the phase I/II ALEXANDER trial of AUTO3 is slated to be presented during the European Society for Medical Oncology (ESMO) conference on September 18. Initial data reported from this study in June demonstrated a complete response rate of 63%, with no patient experiencing neurotoxicity of any grade.

AUTL closed Friday's trading at $12.65, down 0.94%.

2. Ayala Pharmaceuticals Inc. (AYLA)

Ayala Pharma is a clinical-stage oncology company developing drugs for patients suffering from rare and aggressive cancers.

The company's lead drug candidate is AL101, which is under a phase II study for the treatment of patients with recurrent/metastatic adenoid cystic carcinoma, dubbed ACCURACY.

Event:

New interim data from the phase II ACCURACY study of AL101 for the treatment of recurrent/metastatic Adenoid Cystic Carcinoma is slated to be presented at the ESMO Virtual Congress on September 18.

AYLA closed Friday's trading at $9.98, up 4.61%.

3. Eton Pharmaceuticals Inc. (ETON)

Eton Pharma is a revenue-generating specialty pharmaceutical company and it has six product candidates submitted to the FDA and two additional product candidates that are expected to be submitted before the end of this year.

Catalyst:

EM-100, an over-the-counter preservative-free formulation of ketotifen ophthalmic solution, proposed for the treatment of ocular itching associated with allergic conjunctivitis, is under FDA review - with a decision expected on September 15.

Eton Pharma out-licensed EM-100 to Bausch Health Companies Inc. (BHC) in 2019.

ETON closed Friday's trading at $7.70, up 1.05%.

4. Immutep Limited (IMMP)

Immutep is a clinical-stage biotechnology company developing immunotherapy for cancer and autoimmune diseases.

The lead drug candidate is Eftilagimod alpha currently under clinical trials as a treatment in combination with chemotherapy or immune therapy for breast cancer and melanoma.

Catalyst:

Initial results from a phase II study of Eftilagimod alpha with Merck's Keytruda in non-small cell lung carcinoma and head and neck carcinoma patients, dubbed TACTI-002, are slated to be presented on September 17.

IMMP closed Friday's trading at $1.61, up 0.62%.

5. Mallinckrodt plc (MNK)

Mallinckrodt manufactures and markets specialty pharmaceutical products and therapies. Burdened by debt and an onslaught of opioid lawsuits, the company is mulling a possible filing for bankruptcy.

Catalyst:

The FDA decision on the company's Terlipressin, proposed for the treatment of adults with hepatorenal syndrome type 1, an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis, due on September 12 is awaited.

Terlipressin won the FDA panel backing by a narrow margin of 8-7 in July. The FDA usually follows the panels' advice although it is not mandatory.

Outside the U.S. and Canada, Terlipressin is approved and is marketed under the brand name Erliso.

MNK closed Friday's trading at $1.20, down 7.69%.

6. Mersana Therapeutics Inc. (MRSN)

Mersana Therapeutics is a clinical-stage biopharmaceutical company developing antibody-drug conjugates (ADCs) targeting cancers.

The company's lead drug candidate is XMT-1536, which is in the expansion portion of a phase I proof-of-concept clinical study in patients with ovarian cancer and NSCLC adenocarcinoma.

Event:

The updated interim data from the ovarian cancer cohort of the ongoing phase I expansion study of XMT-1536 is scheduled to be presented in an on-demand e-poster display at the 2020 European Society of Medical Oncology (ESMO) Virtual Congress on September 17. The initial interim data from the phase I expansion study of XMT-1536, reported in May of this year, demonstrated a 35% objective response rate, including 10% complete response rate, and 80% disease control rate among twenty evaluable patients with ovarian cancer.

MRSN closed Friday's trading at $18.65, up 1.25%.

7. Verastem Inc. (VSTM)

Verastem is a biopharmaceutical company developing and commercializing new medicines for cancer.

The company markets Copiktra, a drug for the treatment relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory follicular lymphoma (FL).

The lead drug candidate in the pipeline is VS-6766, currently being investigated in an investigator-initiated phase I/II study in combination with Defactinib in low grade serous ovarian cancer (LGSOC), KRAS mutant non-small cell lung cancer (NSCLC), and colorectal cancer (CRC), dubbed FRAME.

Event:

The updated data from the LGSOC cohort of the FRAME study is slated to be presented at the 2nd Annual RAS-Targeted Drug Development Conference on September 16. The preliminary data from the LGSOC cohort of the FRAME study were reported in April this year, which demonstrated an overall response rate (ORR) of 67%.

VSTM closed Friday's trading at $1.22, up 0.83%.

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